Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
Study NCT ID:
NCT00461734
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2007-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gerald.kaye@health.qld.gov.au', 'phone': '07 3176 2111', 'title': 'Dr. Gerald Kaye', 'organization': 'Princess Alexandra Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '5 years', 'eventGroups': [{'id': 'EG000', 'title': 'RV Apex', 'description': 'RV lead placement site: Patients randomised to RV apical lead placement site', 'otherNumAtRisk': 120, 'otherNumAffected': 6, 'seriousNumAtRisk': 120, 'seriousNumAffected': 78}, {'id': 'EG001', 'title': 'RV High Septum', 'description': 'RV lead placement site: Patients randomised to RV high septal lead placement site', 'otherNumAtRisk': 120, 'otherNumAffected': 0, 'seriousNumAtRisk': 120, 'seriousNumAffected': 81}], 'otherEvents': [{'term': 'musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'SOB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 34, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 50, 'numAffected': 29}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'diabets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'rectal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'bile duct', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'angiography', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 15, 'numAffected': 8}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'prostate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': "raynaud's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'product issue', 'notes': "Adverse events related to the pacemaker (e.g., lead dislodgment or changing in threshold values). The term 'product issue' is taken from MedDRA 19.0 classification.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Apex', 'description': 'RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)'}, {'id': 'OG001', 'title': 'RV High Septum', 'description': 'RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.29', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '-3.43', 'spread': '8.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4347', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'two-sided z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At 2-year follow-up', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Cohort with data available'}, {'type': 'PRIMARY', 'title': 'Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Apex', 'description': 'RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)'}, {'id': 'OG001', 'title': 'RV High Septum', 'description': 'RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.04', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '-3.60', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.338', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'two-sided z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At 2-year follow-up', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Cohort with data available'}, {'type': 'SECONDARY', 'title': 'Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Apex', 'description': 'RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)'}, {'id': 'OG001', 'title': 'RV High Septum', 'description': 'RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)'}], 'classes': [{'categories': [{'measurements': [{'value': '56.47', 'spread': '22.61', 'groupId': 'OG000'}, {'value': '24.11', 'spread': '14.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2257', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At 2-year follow-up', 'unitOfMeasure': 'minutes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Cohort with data available'}, {'type': 'SECONDARY', 'title': 'Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Apex', 'description': 'RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)'}, {'id': 'OG001', 'title': 'RV High Septum', 'description': 'RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)'}], 'classes': [{'categories': [{'measurements': [{'value': '40.98', 'spread': '20.04', 'groupId': 'OG000'}, {'value': '6.66', 'spread': '4.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5480', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At 2-year follow-up', 'unitOfMeasure': 'minutes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Cohort with data available'}, {'type': 'SECONDARY', 'title': 'Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Apex', 'description': 'RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)'}, {'id': 'OG001', 'title': 'RV High Septum', 'description': 'RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)'}], 'classes': [{'categories': [{'measurements': [{'value': '17.73', 'spread': '11.95', 'groupId': 'OG000'}, {'value': '63.83', 'spread': '36.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8868', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At 5-years follow-up (study extension)', 'unitOfMeasure': 'minutes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Cohort with data available'}, {'type': 'SECONDARY', 'title': 'Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Apex', 'description': 'RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)'}, {'id': 'OG001', 'title': 'RV High Septum', 'description': 'RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)'}], 'classes': [{'categories': [{'measurements': [{'value': '62.75', 'spread': '36.21', 'groupId': 'OG000'}, {'value': '18.61', 'spread': '16.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6151', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At 5-year follow-up (study extension)', 'unitOfMeasure': 'minutes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Cohort with data available'}, {'type': 'SECONDARY', 'title': 'Worsening of Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Apex', 'description': 'RV lead placement site: Patients randomised to RV apical lead placement site'}, {'id': 'OG001', 'title': 'RV High Septum', 'description': 'RV lead placement site: Patients randomised to RV high septal lead placement site'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 5-year follow-up (study extension)', 'description': 'Worsening of heart failure can be defined as:\n\n1. Heart failure-related hospitalization requiring intravenous heart failure therapy, or\n2. Emergency department visit for heart failure requiring intravenous heart failure therapy, or\n3. Any other visit in which the patient presents with signs or symptoms consistent with heart failure or heart failure exacerbation or marked decline in ejection fraction \\<35%, and intravenous heart failure therapy is required or titrate therapy.\n4. CRT-P or CRT-D upgrade.', 'unitOfMeasure': 'episodes', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Apex', 'description': 'RV lead placement site: Patients randomised to RV apical lead placement site'}, {'id': 'OG001', 'title': 'RV High Septum', 'description': 'RV lead placement site: Patients randomised to RV high septal lead placement site'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 5-year follow-up (study extension)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Apex', 'description': 'RV lead placement site: Patients randomised to RV apical lead placement site'}, {'id': 'OG001', 'title': 'RV High Septum', 'description': 'RV lead placement site: Patients randomised to RV high septal lead placement site'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 5-year follow-up (study extension)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Brain Natriuretic Peptide Levels (Intent to Treat Cohort)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Apex', 'description': 'RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)'}, {'id': 'OG001', 'title': 'RV High Septum', 'description': 'RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to trat cohort)'}], 'classes': [{'categories': [{'measurements': [{'value': '138.2', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1428'}, {'value': '111.3', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '1536'}]}]}], 'analyses': [{'pValue': '0.0525', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'At 2-year follow-up', 'unitOfMeasure': 'picograms per milliliter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Cohort with data available'}, {'type': 'SECONDARY', 'title': 'Brain Natriuretic Peptide Levels (Per Protocol Cohort)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Apex', 'description': 'RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)'}, {'id': 'OG001', 'title': 'RV High Septum', 'description': 'RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)'}], 'classes': [{'categories': [{'measurements': [{'value': '176.6', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1428'}, {'value': '110.8', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '1429'}]}]}], 'analyses': [{'pValue': '0.1852', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'At 2-year follow-up', 'unitOfMeasure': 'picograms per milliliter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Cohort with data available'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Measures of Left Ventricular Dyssynchrony', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Apex', 'description': 'RV lead placement site: Patients randomised to RV apical lead placement site'}, {'id': 'OG001', 'title': 'RV High Septum', 'description': 'RV lead placement site: Patients randomised to RV high septal lead placement site'}], 'timeFrame': 'At 2-year follow-up', 'description': 'No analysis has been done for this section since that variable was not collected during the study.', 'reportingStatus': 'POSTED', 'populationDescription': 'No analysis has been done for this section since that variable was not collected during the study'}, {'type': 'SECONDARY', 'title': '6 Minute Hall-Walk Distance (Intent to Treat Cohort)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Apex', 'description': 'RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)'}, {'id': 'OG001', 'title': 'RV High Septum', 'description': 'RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)'}], 'classes': [{'categories': [{'measurements': [{'value': '391', 'groupId': 'OG000', 'lowerLimit': '307', 'upperLimit': '475'}, {'value': '395', 'groupId': 'OG001', 'lowerLimit': '320', 'upperLimit': '463.25'}]}]}], 'analyses': [{'pValue': '0.9719', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'At 2-year follow-up', 'unitOfMeasure': 'meters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Cohort with data available'}, {'type': 'SECONDARY', 'title': '6 Minute Hall-Walk Distance (Per Protocol Cohort)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Apex', 'description': 'RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)'}, {'id': 'OG001', 'title': 'RV High Septum', 'description': 'RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)'}], 'classes': [{'categories': [{'measurements': [{'value': '385.5', 'groupId': 'OG000', 'lowerLimit': '304.5', 'upperLimit': '477.5'}, {'value': '426.5', 'groupId': 'OG001', 'lowerLimit': '355.5', 'upperLimit': '480'}]}]}], 'analyses': [{'pValue': '0.8779', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'At 2-year follow-up', 'unitOfMeasure': 'meters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Cohort with data available'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RV Apex', 'description': 'RV lead placement site: Patients randomised to RV apical lead placement site'}, {'id': 'FG001', 'title': 'RV High Septum', 'description': 'RV lead placement site: Patients randomised to RV high septal lead placement site'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '60'}]}]}], 'preAssignmentDetails': 'Partecipants initially assessed for eligibility were 248 of whom 8 were excluded before the randomization due to the following causes:\n\n* 4 failed inclusion/exclusion criteria\n* 2 cheanged medical condition resulting no longer eligible\n* 1 had a non-pacemaker procedure\n* 1 the site was aware of his/her randomization code in the envelope'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'RV Apex', 'description': 'RV lead placement site: Patients randomised to RV apical lead placement site'}, {'id': 'BG001', 'title': 'RV High Septum', 'description': 'RV lead placement site: Patients randomised to RV high septal lead placement site'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.7', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '74.7', 'spread': '10', 'groupId': 'BG001'}, {'value': '74.2', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'New Zealand', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-14', 'studyFirstSubmitDate': '2007-04-17', 'resultsFirstSubmitDate': '2016-09-15', 'studyFirstSubmitQcDate': '2007-04-17', 'lastUpdatePostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-14', 'studyFirstPostDateStruct': {'date': '2007-04-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort).', 'timeFrame': 'At 2-year follow-up'}, {'measure': 'Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort).', 'timeFrame': 'At 2-year follow-up'}], 'secondaryOutcomes': [{'measure': 'Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)', 'timeFrame': 'At 2-year follow-up'}, {'measure': 'Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)', 'timeFrame': 'At 2-year follow-up'}, {'measure': 'Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)', 'timeFrame': 'At 5-years follow-up (study extension)'}, {'measure': 'Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)', 'timeFrame': 'At 5-year follow-up (study extension)'}, {'measure': 'Worsening of Heart Failure', 'timeFrame': 'At 5-year follow-up (study extension)', 'description': 'Worsening of heart failure can be defined as:\n\n1. Heart failure-related hospitalization requiring intravenous heart failure therapy, or\n2. Emergency department visit for heart failure requiring intravenous heart failure therapy, or\n3. Any other visit in which the patient presents with signs or symptoms consistent with heart failure or heart failure exacerbation or marked decline in ejection fraction \\<35%, and intravenous heart failure therapy is required or titrate therapy.\n4. CRT-P or CRT-D upgrade.'}, {'measure': 'All Cause Mortality', 'timeFrame': 'At 5-year follow-up (study extension)'}, {'measure': 'Incidence of Stroke', 'timeFrame': 'At 5-year follow-up (study extension)'}, {'measure': 'Brain Natriuretic Peptide Levels (Intent to Treat Cohort)', 'timeFrame': 'At 2-year follow-up'}, {'measure': 'Brain Natriuretic Peptide Levels (Per Protocol Cohort)', 'timeFrame': 'At 2-year follow-up'}, {'measure': 'Echocardiographic Measures of Left Ventricular Dyssynchrony', 'timeFrame': 'At 2-year follow-up', 'description': 'No analysis has been done for this section since that variable was not collected during the study.'}, {'measure': '6 Minute Hall-Walk Distance (Intent to Treat Cohort)', 'timeFrame': 'At 2-year follow-up'}, {'measure': '6 Minute Hall-Walk Distance (Per Protocol Cohort)', 'timeFrame': 'At 2-year follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Right Ventricular High Septal Pacing', 'Right Ventricular Apical Pacing', 'Left Ventricular Dysfunction', 'Heart Block', 'Pacemaker', 'Atrial Fibrillation', 'Ejection Fraction'], 'conditions': ['Left Ventricular Dysfunction']}, 'referencesModule': {'references': [{'pmid': '26517949', 'type': 'DERIVED', 'citation': 'Saito M, Iannaccone A, Kaye G, Negishi K, Kosmala W, Marwick TH; PROTECT-PACE investigators. Effect of Right Ventricular Pacing on Right Ventricular Mechanics and Tricuspid Regurgitation in Patients With High-Grade Atrioventricular Block and Sinus Rhythm (from the Protection of Left Ventricular Function During Right Ventricular Pacing Study). Am J Cardiol. 2015 Dec 15;116(12):1875-82. doi: 10.1016/j.amjcard.2015.09.041. Epub 2015 Oct 9.'}, {'pmid': '25862716', 'type': 'DERIVED', 'citation': 'Kosmala W, Saito M, Kaye G, Negishi K, Linker N, Gammage M, Marwick TH; Protect-Pace Investigators. Incremental value of left atrial structural and functional characteristics for prediction of atrial fibrillation in patients receiving cardiac pacing. Circ Cardiovasc Imaging. 2015 Apr;8(4):e002942. doi: 10.1161/CIRCIMAGING.114.002942.'}, {'pmid': '25666325', 'type': 'DERIVED', 'citation': 'Saito M, Kaye G, Negishi K, Linker N, Gammage M, Kosmala W, Marwick TH; Protect-Pace investigators. Dyssynchrony, contraction efficiency and regional function with apical and non-apical RV pacing. Heart. 2015 Apr;101(8):600-8. doi: 10.1136/heartjnl-2014-306990. Epub 2015 Feb 9.'}, {'pmid': '25189602', 'type': 'DERIVED', 'citation': 'Kaye GC, Linker NJ, Marwick TH, Pollock L, Graham L, Pouliot E, Poloniecki J, Gammage M; Protect-Pace trial investigators. Effect of right ventricular pacing lead site on left ventricular function in patients with high-grade atrioventricular block: results of the Protect-Pace study. Eur Heart J. 2015 Apr 7;36(14):856-62. doi: 10.1093/eurheartj/ehu304. Epub 2014 Sep 4.'}]}, 'descriptionModule': {'briefSummary': 'This study will be done in patients who require the implantation of a cardiac pacemaker (an electronic device that controls the heartbeat) for complete heart block (a heart rhythm abnormality resulting in a slow heart beat). Pacemakers regulate the heart beat by delivering pulses of electricity through special wires (pacing leads) which are placed inside the heart.\n\nThis study will compare two groups of pacemaker patients. Each group will have their pacing leads placed in a particular location in the heart. The purpose of the study is to show whether the position used in one group is better for maintaining effective heart function compared to the position used in the other group.\n\nThe leads in one group will be placed in a position called the Right Ventricular Apex. This is the traditional and most frequently used position for pacemaker leads.\n\nThe leads in the other group will be placed in a position called the Right Ventricular High Septum. This is a less commonly used position, but may result in health benefits for the patients compared with the Right Ventricular Apex.', 'detailedDescription': "There is an increasing amount of evidence to suggest that other positions in the heart may be more effective than the conventional Right Ventricular Apex (RVA) position for restoring good heart function. The best site to place a lead has not yet been proven.\n\nThis is a study comparing the long term clinical effects of two different lead positions. The measurements taken to assess the clinical effects include:\n\n* the effectiveness of the heart's pumping action (as measured by ultrasound scans)\n* measurements of how far patients can walk in 6 minutes\n* analysis of blood samples\n* collection of information from the pacemaker about heart rhythm problems\n\nHalf of the patients in the study will receive conventional leads placed in the more common RVA position in the heart. The other half will receive a relatively new type of lead placed in what is called the Right Ventricular High Septal (RVHS) position.\n\nIn order to fairly compare the outcomes of these two different lead positions this study has been designed as a 'randomized', 'blind' trial. This means that the group which patients will be entered into will be chosen at random and patients will not be told which group they are in.\n\nPatients will each have an equal (50:50) chance of being in either group. By carefully comparing the clinical differences between the two groups of patients, the study aims to prove whether or not there are additional benefits for patients when the RVHS lead position is used.\n\nAll leads used in the study have been shown to be safe for patients and are available commercially for implantation. All of the implanting doctors involved in the study are experienced at implanting the pacemakers and leads that will be used in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with high grade AV block and sinus rhythm, scheduled to undergo dual chamber pacemaker implantation OR patients with high grade AV block and permanent atrial fibrillation, scheduled to undergo single chamber ventricular pacemaker implantation.\n* Patients aged 18 years or older.\n\nExclusion Criteria:\n\n* Patients indicated for an Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy.\n* Patients following junctional ablation.\n* Patients with a Myocardial Infarction within three months prior to enrollment.\n* Patients that received bypass surgery within three months prior to enrollment.\n* Patients that had a valve replacement within three months prior to enrollment or patients with a mechanical right heart valve.\n* Patients where a right ventricular lead cannot be placed i.e. complex congenital heart disease.\n* Patients with hypertrophic obstructive cardiomyopathy.\n* Patients with acute coronary syndrome, unstable angina, severe mitral regurgitation and/or hemodynamically significant aortic stenosis.\n* Previous implanted pacemaker or cardioverter defibrillator.\n* Known paroxysmal atrial fibrillation or a documented episode of atrial fibrillation prior to enrollment.\n* Patients on amiodarone therapy within the last six months prior to enrollment.\n* Terminal conditions with a life expectancy of less than two years.\n* Participation in any other study that would confound the results of this study.\n* Psychological or emotional problems that may interfere with the volunteer's ability to provide full consent or fully understand the purposes of the study.\n* Pregnant patients or patients who may become pregnant during the time-scale of the study."}, 'identificationModule': {'nctId': 'NCT00461734', 'acronym': 'PROTECT-PACE', 'briefTitle': 'PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing. Does Right Ventricular High-septal Pacing Improve Outcome Compared With Right Ventricular Apical Pacing?', 'orgStudyIdInfo': {'id': 'PROTECT-PACE Version 4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RV Apex', 'interventionNames': ['Other: RV lead placement site']}, {'type': 'EXPERIMENTAL', 'label': 'RV High Septum', 'interventionNames': ['Other: RV lead placement site']}], 'interventions': [{'name': 'RV lead placement site', 'type': 'OTHER', 'description': 'Patients randomised to RV apical or high septal lead placement site', 'armGroupLabels': ['RV Apex', 'RV High Septum']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': "Royal Brisbane & Womens' Hospital", 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'The Prince Charles Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Calvary Wakefield Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Flinders Medical Center', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Christchurch Hospital', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'city': 'Blackpool', 'country': 'United Kingdom', 'facility': 'Blackpool Victoria Hospital', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth Hospital', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'University Hospital of Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'city': 'Colchester', 'country': 'United Kingdom', 'facility': 'Colchester General', 'geoPoint': {'lat': 51.88921, 'lon': 0.90421}}, {'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds General Infirmary', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "St. Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Middlesbrough', 'country': 'United Kingdom', 'facility': 'James Cook University Hospital', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University Hospital', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'city': 'Orpington, Kent', 'country': 'United Kingdom', 'facility': 'Princess Royal Hospital'}, {'city': 'Wolverhampton', 'country': 'United Kingdom', 'facility': 'New Cross Hospital', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}], 'overallOfficials': [{'name': 'Dr. Gerald Kaye', 'role': 'STUDY_CHAIR', 'affiliation': 'Princess Alexandra Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}