Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-01-07 @ 6:41 AM
Study NCT ID:
NCT02671903
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2016-01-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The His Optimised Pacing Evaluated for Heart Failure Trial (HOPE-HF).
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'z.whinnett@imperial.ac.uk', 'phone': '+44 (0)20 7594 5735', 'title': 'Dr Zachary I Whinnett', 'organization': 'Imperial College London'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'AE Data presented was collected during the treatment phase of the study. 12 months in total.', 'description': 'Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167.\n\nDue to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157\n\nAll AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm', 'eventGroups': [{'id': 'EG000', 'title': 'Run-in Period (Pre-Randomisation)', 'description': '2-month run-in period post device implantation. Device switched to no pacing during this period.', 'otherNumAtRisk': 167, 'deathsNumAtRisk': 167, 'otherNumAffected': 54, 'seriousNumAtRisk': 167, 'deathsNumAffected': 0, 'seriousNumAffected': 25}, {'id': 'EG001', 'title': 'AV Optimised Direct His-bundle (ARM A at Period 1, ARM B at Period 2)', 'description': 'Adverse Events \\& Mortality grouped by treatment received over the 12-month follow-up period. AV optimised direct His-bundle (ARM A at Period 1, ARM B at Period 2).\n\nNote: Due to withdrawals by period 2, total at risk for Pacing treatment = 160', 'otherNumAtRisk': 160, 'deathsNumAtRisk': 160, 'otherNumAffected': 75, 'seriousNumAtRisk': 160, 'deathsNumAffected': 6, 'seriousNumAffected': 25}, {'id': 'EG002', 'title': 'No Pacing (ARM A at Period 2, ARM B at Period 1)', 'description': 'Adverse Events \\& Mortality grouped by treatment received over the 12-month follow-up period. No Pacing (ARM A at Period 2, ARM B at Period 1)\n\nNote: Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157', 'otherNumAtRisk': 157, 'deathsNumAtRisk': 157, 'otherNumAffected': 75, 'seriousNumAtRisk': 157, 'deathsNumAffected': 4, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'abnormal blood sugar levels', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal LFTs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Accidental morphine overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Baker's cyst", 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bilateral leg cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bilateral numbness of arm when lying either side', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bilateral Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloatedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blocked urethral catheter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac symptoms of palpitations and hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Common Colds', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decompensated Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic Left Foot Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry persistent cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eczema Skin condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of HF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Extreme tiredness and fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall secondary to dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling of generally unwell', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fractured foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematuria secondary to NOAC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HIS lead threshold rise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospital Acquired Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypergylcaemic Episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Idiopathic skin condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Impacted ear wax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased breathlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intermittent cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laceration to big toe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left eye vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left Kidney Stones', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mechanical Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'mouth ulcer requiring biopsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New diagnosis of diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nonblanching petechial rashes on both shins', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-sustained VT Episodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Painful bilateral knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'painful lower extremeties', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paroxysmal Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 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'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleep Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Slight palpitations, Chest discomfort.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ST elevation on ECG post MVO2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swollen right leg ?secondary to blood clot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 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'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Community Acquired Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Complete Heart Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decompensated / Congestive Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulcerated legs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'His Lead displacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ICD shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LRTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaphylactic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney Disease', 'notes': 'Acute on Chronic Kidney Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AKI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Raised His Lead Threshold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subclavian vein thrombosis.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VT Episodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Exercise Capacity.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pacing', 'description': 'Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).'}, {'id': 'OG001', 'title': 'No-Pacing', 'description': 'No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': '15.0'}, {'value': '13.7', 'groupId': 'OG001', 'lowerLimit': '12.8', 'upperLimit': '14.6'}]}]}], 'analyses': [{'pValue': '0.3', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Fixed Effect for Treatment', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.73', 'groupDescription': 'Change in treatment effect taken from mixed-model output', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Measured using peak oxygen uptake (VO2).', 'unitOfMeasure': 'ml/min/kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Changes in Echocardiographic Measurement of Left Ventricular Function (Ejection Fraction)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pacing', 'description': 'Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).'}, {'id': 'OG001', 'title': 'No-Pacing', 'description': 'No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.4', 'groupId': 'OG000', 'lowerLimit': '31.2', 'upperLimit': '35.7'}, {'value': '33.0', 'groupId': 'OG001', 'lowerLimit': '31.0', 'upperLimit': '34.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Measured during echocardiogram.', 'unitOfMeasure': '% (LVEF)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Changes in B-type Naturietic Peptide (BNP).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pacing', 'description': 'Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).'}, {'id': 'OG001', 'title': 'No-Pacing', 'description': 'No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '323', 'groupId': 'OG000', 'lowerLimit': '242', 'upperLimit': '431'}, {'value': '335', 'groupId': 'OG001', 'lowerLimit': '257', 'upperLimit': '436'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Measured from blood sample. Note: BNP was log-transformed before analysis in the mixed-model and then back transformed for presentation', 'unitOfMeasure': '(ng/L)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Changes in Quality of Life Scores. - Minnesota', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pacing', 'description': 'Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).'}, {'id': 'OG001', 'title': 'No-Pacing', 'description': 'Following a lead-in period of No-Pacing subjects will be placed under No-Pacing before being crossed-over to Direct His bundle pacing'}], 'classes': [{'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000', 'lowerLimit': '25.1', 'upperLimit': '36.7'}, {'value': '34.6', 'groupId': 'OG001', 'lowerLimit': '29.8', 'upperLimit': '39.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Measured using Minnesota Score obtained from the Minnesota Living with Heart Failure Questionnaire (MLHFQ).\n\nScore range: 0 to 105, with higher scores indicating a worse outcome with more significant impairment in health-related quality of life', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT - Note that some patients were not able to be analysed due to providing no questionnaire data.'}, {'type': 'SECONDARY', 'title': 'Cost Effectiveness Analysis (Using a Custom Designed Resource Utilisation Questionnaire)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ARM A (Pacemaker: AV Optimised, His Pacing --> No PAcing)', 'description': 'Subjects will remain in this arm for 6 months before being crossed-over. See below intervention details.\n\nPacemaker: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).'}, {'id': 'OG001', 'title': 'ARM B (No Pacing --> Pacemaker: AV Optimised, His Pacing)', 'description': 'Subjects will remain in this arm for 6 months before being crossed-over. The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.'}], 'timeFrame': 'Baseline.', 'description': 'The analysis will be based on an intention-to-treat (ITT) principle. The economic evaluation will compare incremental costs and incremental outcomes of the direct His-bundle pacing against the standard medical care. The study will be performed from a societal perspective, which takes all relevant cost-categories and effects into account. The economic evaluation will consist of two parts, a cost-effectiveness analysis (CEA) and a cost utility analysis (CUA). In the CEA the incremental cost-effectiveness ratio (ICER) will be expressed as the incremental costs per point improvement in exercise capacity in peak VO2. The primary outcome measure in the CUA will be Qualitative Adjusted Life Years (QALYs), based on the EQ5D and Minnesota questionnaire scores.\n\nNOTE: Cost effectiveness was unable to be completed for HOPE-HF and as such null results are displayed', 'reportingStatus': 'POSTED', 'populationDescription': 'NOTE: Cost effectiveness was unable to be completed for HOPE-HF and as such null results are displayed'}, {'type': 'SECONDARY', 'title': 'Changes in Percentage Pacing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Pacing Followed by No-Pacing', 'description': 'Following a lead-in period of No-Pacing subjects will be placed under Direct His bundle pacing before being crossed-over to No-Pacing.\n\nSee below intervention details.\n\nPacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).'}, {'id': 'OG001', 'title': 'Arm B: No-Pacing Followed by Pacing', 'description': 'Following a lead-in period of No-Pacing subjects will be placed under No-Pacing before being crossed-over to Direct His bundle pacing.\n\nSee below intervention details.\n\nNo-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.\n\nPacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).'}], 'classes': [{'title': 'M6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.8', 'spread': '19.42', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '11.59', 'groupId': 'OG000'}, {'value': '93.5', 'spread': '16.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Measured at completion of periods 1 \\& 2 (M6 \\& M12) - Percentage of time where device recorded ventricular pacing during each treatment period. Values are recorded across both arms.\n\nResults are descriptive and displayed by treatment and by period.', 'unitOfMeasure': '% (of time over period)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT - Note that results are presented per sequence (e.g, by arm per study period) due to the nature of this particular endpoint. Outcome is based on when participants are on Pacing therapy and as such a per-protocol analysis would read zero for any period when not on pacing.'}, {'type': 'SECONDARY', 'title': 'Changes in Arrythmia Burden (%).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Pacing Followed by No-Pacing', 'description': 'Following a lead-in period of No-Pacing subjects will be placed under Direct His bundle pacing before being crossed-over to No-Pacing.\n\nSee below intervention details.\n\nPacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).\n\nNo-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.'}, {'id': 'OG001', 'title': 'Arm B: No-Pacing Followed by Pacing', 'description': 'Following a lead-in period of No-Pacing subjects will be placed under No-Pacing before being crossed-over to Direct His bundle pacing.\n\nSee below intervention details.\n\nNo-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.\n\nPacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).'}], 'classes': [{'title': 'BL (Randomisation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '2.40', 'groupId': 'OG001'}]}]}, {'title': 'M6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '11.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Measured upon completion of run-in (as baseline) and periods 1 \\& 2 (M6 \\& M12). Device detected Atrial Fibrillation/Supraventricular Tachycardia (AF/SVT) burden recorded as a percentage of time over the 6-month treatment period.\n\nResults are descriptive and displayed by treatment and by period.', 'unitOfMeasure': '% (time under AF/SVT burden)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT - Note that results are presented per sequence (e.g, by arm per study period) due to the nature of this particular endpoint.'}, {'type': 'SECONDARY', 'title': 'Changes in Pacing Thresholds (Volts).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Pacing Followed by No-Pacing', 'description': 'Following a lead-in period of No-Pacing subjects will be placed under Direct His bundle pacing before being crossed-over to No-Pacing.\n\nSee below intervention details.\n\nPacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).\n\nNo-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.'}, {'id': 'OG001', 'title': 'Arm B: No-Pacing Followed by Pacing', 'description': 'Following a lead-in period of No-Pacing subjects will be placed under No-Pacing before being crossed-over to Direct His bundle pacing.\n\nSee below intervention details.\n\nNo-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.\n\nPacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).'}], 'classes': [{'title': 'RA Lead - BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.972', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.510', 'groupId': 'OG001'}]}]}, {'title': 'RA Lead - M6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.82', 'spread': '1.090', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.645', 'groupId': 'OG001'}]}]}, {'title': 'RA Lead - M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '1.034', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.938', 'groupId': 'OG001'}]}]}, {'title': 'LV Lead - BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.438', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.516', 'groupId': 'OG001'}]}]}, {'title': 'LV Lead - M6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.452', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.265', 'groupId': 'OG001'}]}]}, {'title': 'LV Lead - M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.359', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.280', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Measured upon completion of run-in and periods 1 \\& 2 (BL, M6 \\& M12)\n\nResults are descriptive and displayed by treatment and by period. Please also note that voltage is presented for both RA Lead and LV Lead.', 'unitOfMeasure': 'Volts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT - Note that results are presented per sequence (e.g, by arm per study period) due to the nature of this particular endpoint. Outcome is based on when participants are on Pacing therapy and as such a per-protocol analysis would read zero for any period when not on pacing.'}, {'type': 'SECONDARY', 'title': 'Changes in R Wave Amplitude.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Pacing Followed by No-Pacing', 'description': 'Following a lead-in period of No-Pacing subjects will be placed under Direct His bundle pacing before being crossed-over to No-Pacing.\n\nSee below intervention details.\n\nPacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).'}, {'id': 'OG001', 'title': 'Arm B: No-Pacing Followed by Pacing', 'description': 'Following a lead-in period of No-Pacing subjects will be placed under No-Pacing before being crossed-over to Direct His bundle pacing.\n\nSee below intervention details.\n\nNo-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.\n\nPacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).'}], 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Measured from electrocardiogram (ECG).', 'reportingStatus': 'POSTED', 'populationDescription': 'Null analysis population as r-wave data was unable to be collected'}, {'type': 'SECONDARY', 'title': 'Changes in Lead Impedance (Ohms).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Pacing Followed by No-Pacing', 'description': 'Following a lead-in period of No-Pacing subjects will be placed under Direct His bundle pacing before being crossed-over to No-Pacing.\n\nSee below intervention details.\n\nPacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).\n\nNo-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.'}, {'id': 'OG001', 'title': 'Arm B: No-Pacing Followed by Pacing', 'description': 'Following a lead-in period of No-Pacing subjects will be placed under No-Pacing before being crossed-over to Direct His bundle pacing.\n\nSee below intervention details.\n\nNo-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.\n\nPacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).'}], 'classes': [{'title': 'RA Lead Impedance - BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '460.8', 'spread': '66.7', 'groupId': 'OG000'}, {'value': '480.8', 'spread': '89.24', 'groupId': 'OG001'}]}]}, {'title': 'RA Lead Impedance - M6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '475.2', 'spread': '62.44', 'groupId': 'OG000'}, {'value': '469.1', 'spread': '86.48', 'groupId': 'OG001'}]}]}, {'title': 'RA Lead Impedance - M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '452.0', 'spread': '68.38', 'groupId': 'OG000'}, {'value': '473.7', 'spread': '110.6', 'groupId': 'OG001'}]}]}, {'title': 'His Lead Impedance - BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '377.9', 'spread': '104.28', 'groupId': 'OG000'}, {'value': '392.4', 'spread': '97.94', 'groupId': 'OG001'}]}]}, {'title': 'His Lead Impedance - M6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '326.3', 'spread': '84.24', 'groupId': 'OG000'}, {'value': '326.8', 'spread': '87.08', 'groupId': 'OG001'}]}]}, {'title': 'His Lead Impedance - M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '324.9', 'spread': '87.08', 'groupId': 'OG000'}, {'value': '330.6', 'spread': '82.68', 'groupId': 'OG001'}]}]}, {'title': 'LV Lead Impedance - BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '436.5', 'spread': '90.85', 'groupId': 'OG000'}, {'value': '464.8', 'spread': '101.62', 'groupId': 'OG001'}]}]}, {'title': 'LV Lead Impedance - M6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '427.8', 'spread': '87.01', 'groupId': 'OG000'}, {'value': '439.1', 'spread': '109.44', 'groupId': 'OG001'}]}]}, {'title': 'LVLead Impedance - M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '425.8', 'spread': '85.06', 'groupId': 'OG000'}, {'value': '431.2', 'spread': '9.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Measured upon completion of run-in and periods 1 \\& 2 (BL, M6 \\& M12).\n\nResults are descriptive and displayed by treatment and by period. Please also note that lead impedance is presented for both RA Lead, HIS-Lead and LV Lead.', 'unitOfMeasure': 'ohms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '\\- Note that results are presented per sequence (e.g, by arm per study period) due to the nature of this particular endpoint.'}, {'type': 'SECONDARY', 'title': 'Fluoroscopy Time During Device Insertion.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Pacing Followed by No-Pacing', 'description': 'Device insertion time for those allocated to Arm A'}, {'id': 'OG001', 'title': 'Arm B: No-Pacing Followed by Pacing', 'description': 'Device insertion time for those allocated to Arm B'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '27'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Taken at Device Insertion Visit (2). Baseline measure.', 'description': 'Measured by time in minutes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT - Note that 2 patients (1 in each arm) have missing data. This outcome measure is only based on the device insertion and does not have a cross-over element.'}, {'type': 'SECONDARY', 'title': 'Changes in Quality of Life Scores. - EQ5D Health State Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pacing', 'description': 'Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).'}, {'id': 'OG001', 'title': 'No-Pacing', 'description': 'No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.3', 'groupId': 'OG000', 'lowerLimit': '61.0', 'upperLimit': '71.6'}, {'value': '64.3', 'groupId': 'OG001', 'lowerLimit': '60.4', 'upperLimit': '68.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Taken from the Visual Analog Scale (VAS) Score from EQ5D Health State Question in EuroQol, 5-dimension, 5-level (EQ5D5L) questionnaire.\n\nScore is on a 0-100 scale with 100 representing a better outcome for patients health state.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT - Note that some patients were not able to be analysed due to providing no questionnaire data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: Pacing Followed by No-Pacing', 'description': 'Following a lead-in period of No-Pacing subjects will be placed under Direct His bundle pacing before being crossed-over to No-Pacing.\n\nSee below intervention details.\n\nPacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).\n\nNo-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.'}, {'id': 'FG001', 'title': 'Arm B: No-Pacing Followed by Pacing', 'description': 'Following a lead-in period of No-Pacing subjects will be placed under No-Pacing before being crossed-over to Direct His bundle pacing.\n\nSee below intervention details.\n\nNo-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.\n\nPacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).'}, {'id': 'FG002', 'title': 'Run-In Phase (Pre-Randomisation)', 'description': '2-month run-in period for ALL patients post implantation of pacemaker. Set at No-Pacing.'}], 'periods': [{'title': 'Period 0 (Run-In)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Any patient that fails to the complete the run-in period are subsequently not randomised to a treatment Arm.', 'groupId': 'FG002', 'numSubjects': '183'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '167'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Implantation Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Period 1 (Month 0 to Month 6)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Post Randomisation, Patients now allocated to Arm A or Arm B', 'groupId': 'FG000', 'numSubjects': '83'}, {'comment': 'Post Randomisation, Patients now allocated to Arm A or Arm B', 'groupId': 'FG001', 'numSubjects': '84'}, {'comment': 'Post Randomisation, Patients now allocated to Arm A or Arm B', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'comment': 'Post Randomisation, Patients now allocated to Arm A or Arm B', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period 2 (Month 6 to Month 12)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'comment': 'Post Randomisation, Patients now allocated to Arm A or Arm B', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'comment': 'Post Randomisation, Patients now allocated to Arm A or Arm B', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Patients have a pacemaker device implanted and are subject to a 2-month run-in phase prior to randomisation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: Pacing Followed by No-Pacing', 'description': 'Following a lead-in period of No-Pacing subjects will be placed under Direct His bundle pacing before being crossed-over to No-Pacing.\n\nSee below intervention details.\n\nPacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).\n\nNo-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.'}, {'id': 'BG001', 'title': 'Arm B: No-Pacing Followed by Pacing', 'description': 'Following a lead-in period of No-Pacing subjects will be placed under No-Pacing before being crossed-over to Direct His bundle pacing.\n\nSee below intervention details.\n\nNo-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.\n\nPacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.0', 'spread': '9.03', 'groupId': 'BG000'}, {'value': '68.0', 'spread': '10.19', 'groupId': 'BG001'}, {'value': '69.0', 'spread': '9.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Mixed', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Other Ethnic Group', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '85.22', 'spread': '16.788', 'groupId': 'BG000'}, {'value': '89.24', 'spread': '17.636', 'groupId': 'BG001'}, {'value': '87.24', 'spread': '17.286', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '28.498', 'spread': '5.0208', 'groupId': 'BG000'}, {'value': '29.665', 'spread': '5.5027', 'groupId': 'BG001'}, {'value': '29.085', 'spread': '5.2853', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic BP', 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'spread': '11.22', 'groupId': 'BG000'}, {'value': '70.8', 'spread': '11.31', 'groupId': 'BG001'}, {'value': '69.9', 'spread': '11.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic BP', 'classes': [{'categories': [{'measurements': [{'value': '121.3', 'spread': '19.07', 'groupId': 'BG000'}, {'value': '121.7', 'spread': '20.24', 'groupId': 'BG001'}, {'value': '121.5', 'spread': '19.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'ITT Population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-25', 'size': 531539, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-09-28T08:49', 'hasProtocol': True}, {'date': '2020-09-15', 'size': 12586571, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-09-28T08:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2016-01-26', 'resultsFirstSubmitDate': '2023-03-29', 'studyFirstSubmitQcDate': '2016-01-29', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-09', 'studyFirstPostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Exercise Capacity.', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Measured using peak oxygen uptake (VO2).'}], 'secondaryOutcomes': [{'measure': 'Changes in Echocardiographic Measurement of Left Ventricular Function (Ejection Fraction)', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Measured during echocardiogram.'}, {'measure': 'Changes in B-type Naturietic Peptide (BNP).', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Measured from blood sample. Note: BNP was log-transformed before analysis in the mixed-model and then back transformed for presentation'}, {'measure': 'Changes in Quality of Life Scores. - Minnesota', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Measured using Minnesota Score obtained from the Minnesota Living with Heart Failure Questionnaire (MLHFQ).\n\nScore range: 0 to 105, with higher scores indicating a worse outcome with more significant impairment in health-related quality of life'}, {'measure': 'Cost Effectiveness Analysis (Using a Custom Designed Resource Utilisation Questionnaire)', 'timeFrame': 'Baseline.', 'description': 'The analysis will be based on an intention-to-treat (ITT) principle. The economic evaluation will compare incremental costs and incremental outcomes of the direct His-bundle pacing against the standard medical care. The study will be performed from a societal perspective, which takes all relevant cost-categories and effects into account. The economic evaluation will consist of two parts, a cost-effectiveness analysis (CEA) and a cost utility analysis (CUA). In the CEA the incremental cost-effectiveness ratio (ICER) will be expressed as the incremental costs per point improvement in exercise capacity in peak VO2. The primary outcome measure in the CUA will be Qualitative Adjusted Life Years (QALYs), based on the EQ5D and Minnesota questionnaire scores.\n\nNOTE: Cost effectiveness was unable to be completed for HOPE-HF and as such null results are displayed'}, {'measure': 'Changes in Percentage Pacing', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Measured at completion of periods 1 \\& 2 (M6 \\& M12) - Percentage of time where device recorded ventricular pacing during each treatment period. Values are recorded across both arms.\n\nResults are descriptive and displayed by treatment and by period.'}, {'measure': 'Changes in Arrythmia Burden (%).', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Measured upon completion of run-in (as baseline) and periods 1 \\& 2 (M6 \\& M12). Device detected Atrial Fibrillation/Supraventricular Tachycardia (AF/SVT) burden recorded as a percentage of time over the 6-month treatment period.\n\nResults are descriptive and displayed by treatment and by period.'}, {'measure': 'Changes in Pacing Thresholds (Volts).', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Measured upon completion of run-in and periods 1 \\& 2 (BL, M6 \\& M12)\n\nResults are descriptive and displayed by treatment and by period. Please also note that voltage is presented for both RA Lead and LV Lead.'}, {'measure': 'Changes in R Wave Amplitude.', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Measured from electrocardiogram (ECG).'}, {'measure': 'Changes in Lead Impedance (Ohms).', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Measured upon completion of run-in and periods 1 \\& 2 (BL, M6 \\& M12).\n\nResults are descriptive and displayed by treatment and by period. Please also note that lead impedance is presented for both RA Lead, HIS-Lead and LV Lead.'}, {'measure': 'Fluoroscopy Time During Device Insertion.', 'timeFrame': 'Taken at Device Insertion Visit (2). Baseline measure.', 'description': 'Measured by time in minutes.'}, {'measure': 'Changes in Quality of Life Scores. - EQ5D Health State Score', 'timeFrame': 'Baseline, 6 months and 12 months post randomisation.', 'description': 'Taken from the Visual Analog Scale (VAS) Score from EQ5D Health State Question in EuroQol, 5-dimension, 5-level (EQ5D5L) questionnaire.\n\nScore is on a 0-100 scale with 100 representing a better outcome for patients health state.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'This is a multi-centre, prospective randomised double-blinded cross over study, recruiting a sub-population of patients with heart failure.\n\nAll patients will be implanted with a CRT (Cardiac Resynchronisation Therapy) pacemaker with one of the leads positioned on the His bundle in order to obtain direct His-bundle capture. There will be a 2-month run-in period where the device is not active.\n\nA double-blinded cross-over design will then be employed to investigate the effect of His bundle pacing. Patients will be allocated in random order to six month treatment periods in each of the following two states (1) No pacing; (2) AV optimised direct His-bundle pacing. Endpoint measurements will be taken at baseline, 6 months and 12 months post randomisation. Treatment allocation will be blinded to the endpoint assessor and the patient.\n\n126 patients will be needed to detect the expected effect size on the primary endpoint with 90% power. A total of 160 patients will be recruited to allow for patient drop-out.', 'detailedDescription': "Patients entering the study will attend for implantation of a CRT pacemaker device with one lead positioned on the His bundle. This will be performed either at the patient's local hospital or at Imperial College NHS healthcare Trust, no later than 4 months after the patient's screening visit.\n\nAll patients will be implanted with a Pacemaker or Implantable cardioverter defibrillator (ICD). In all patients a pacing lead will be positioned in the right atrium (typically the right atrial appendage). All patients will have a pacemaker lead positioned on the His bundle in order to obtain direct His-bundle capture. If it is not possible to successfully implant a His-bundle lead with selective direct His bundle capture or non-selective capture with \\< 40ms prolongation of the QRS duration, then a lead will be implanted in a lateral branch of the coronary sinus.\n\nIn patients who do not have an indication for an Implantable cardioverter defibrillator (ICD) a second ventricular lead will be implanted in a lateral branch of the coronary sinus. If direct His pacing has not been successfully achieved then a further lead will be positioned at the RV apex. In patients who do have an indication for an Implantable cardioverter defibrillator the ICD lead will be positioned in the right ventricle (either RV apex or RV septum).\n\nAV delay optimisation will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands). The BHF (British Heart Foundation) alternation protocol will be used in order to minimise the effect of background noise.\n\nAfter implantation of the device there will be a 2 month run-in period prior to randomisation, the device will be programmed not to deliver His bundle pacing therapy during this period.(Back up only pacing and defibrillator function will be enabled).\n\nTwo months after patients are implanted with their device, patients will be randomised to either receive active pacing treatment or back up only pacing (pacemaker programmed to VVI 30 bpm). After a further 6 months they will be crossed over to the alternative treatment arm. Treatment allocation will be obtained using an Interactive Web Response System (IWRS) programmed with a randomisation schedule provided by the trial statistician. Appropriate blocking will be used."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 or above\n* Ventricular Ejection Fraction (EF) \\< 40%; BNP needs to be ≥250ng/L for patients with EF 36-40%\n* New York Heart Association (NYHA) class II-IV\n* PR interval ≥200ms\n* Narrow QRS duration (≤140ms) or prolonged QRS duration with typical Right Bundle Branch Block (RBBB) morphology on 12 lead ECG and sinus rhythm\n\nExclusion Criteria:\n\n* Permanent or persistent atrial fibrillation (AF)\n* Paroxysmal atrial fibrillation with history of sustained AF (more than 24 hours) in the 6 months prior to screening\n* Patients who are unable to perform cardiopulmonary exercise testing\n* Other serious medical condition with life expectancy of less than 1 year\n* Lack of capacity to consent\n* Pregnancy\n* Contraindication to use of the relevant study device or leads (as per current manuals from manufacturer)'}, 'identificationModule': {'nctId': 'NCT02671903', 'acronym': 'HOPE-HF', 'briefTitle': 'The His Optimised Pacing Evaluated for Heart Failure Trial (HOPE-HF).', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'AV Optimisation Delivered With Direct His Bundle Pacing, in Patients With Heart Failure, Long PR Without Left Bundle Branch Block: Randomised Multi-centre Clinical Outcome Study.', 'orgStudyIdInfo': {'id': '15HH2828'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pacemaker: AV optimised, His pacing', 'description': 'Subjects will remain in this arm for 6 months before being crossed-over. See below intervention details.', 'interventionNames': ['Device: Pacemaker: AV optimised, His pacing.']}, {'type': 'NO_INTERVENTION', 'label': 'No pacing', 'description': 'Subjects will remain in this arm for 6 months before being crossed-over. The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.'}], 'interventions': [{'name': 'Pacemaker: AV optimised, His pacing.', 'type': 'DEVICE', 'description': 'Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).', 'armGroupLabels': ['Pacemaker: AV optimised, His pacing']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WD18 0HB', 'city': 'Watford', 'state': 'Hertfordshire', 'country': 'United Kingdom', 'facility': 'West Hertfordshire Hospitals NHS Trust', 'geoPoint': {'lat': 51.65531, 'lon': -0.39602}}, {'city': 'Basildon', 'country': 'United Kingdom', 'facility': 'Basildon and Thurrock Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'University Hospitals Birmingham NHS Foundation Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'University Hospitals Bristol NHS Foundation Trust', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Chichester', 'country': 'United Kingdom', 'facility': 'Western Sussex Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 50.83673, 'lon': -0.78003}}, {'city': 'Gillingham', 'country': 'United Kingdom', 'facility': 'Medway NHS Foundation Trust', 'geoPoint': {'lat': 51.38914, 'lon': 0.54863}}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'University Hospitals of Leicester NHS Trust', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'W12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Barts Health NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Brompton & Harefield NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Papworth Everard', 'country': 'United Kingdom', 'facility': 'Papworth Hospital NHS Foundation Trust', 'geoPoint': {'lat': 52.24893, 'lon': -0.11827}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Swindon', 'country': 'United Kingdom', 'facility': 'Great Western Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.55797, 'lon': -1.78116}}], 'overallOfficials': [{'name': 'Zachary Whinnett, BMBS MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Senior Lecturer, Consultant Cardiologist and Electrophysiologist'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '6 months post publication of data', 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication. The data set will be created as an anonymised data sharing package and will be available post publication of data.', 'accessCriteria': 'The anonymised data set will be shared with the journal in which the papers are published.\n\nWe will make the data available for analysis by non-commercial researchers on request to the Chief investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': 'British Heart Foundation', 'class': 'OTHER'}, {'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}