Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-02 @ 3:32 AM
Study NCT ID:
NCT00422669
Status:
TERMINATED
Last Update Posted:
2013-01-31
First Post:
2007-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Optimize RV Selective Site Pacing Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands', 'Serbia', 'Serbia and Montenegro']}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medtroniccrmtrials@medtronic.com', 'phone': '1-800-328-2518', 'title': 'Optimize RV Trial Leader', 'organization': 'Medtronic, Inc.'}, 'certainAgreement': {'otherDetails': 'In most cases, contracts allow investigators ("PI") to publish per the publication strategy/Clinical Investigational Plan following Medtronic\'s review for (a) disclosure of confidential information ("CI"), and (b) selection and order of publications by the publications committee. Any such CI is deleted prior to publication/presentation. Medtronic may not otherwise censor/interfere with the publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Early study termination due to enrollment rates significantly below protocol expectations.'}}, 'adverseEventsModule': {'timeFrame': 'All adverse events reported before the study termination were included.', 'description': 'Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee.\n\nAll serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".', 'eventGroups': [{'id': 'EG000', 'title': 'Subjects With Implant', 'description': 'All 198 subjects with implant were included in this group.', 'otherNumAtRisk': 198, 'otherNumAffected': 12, 'seriousNumAtRisk': 198, 'seriousNumAffected': 50}], 'otherEvents': [{'term': 'Abdominal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cardiac flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Lead dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pacemaker generated arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (10.1)'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cardiac perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cardiac valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Device failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Failure to capture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Implant site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Intracardiac thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Lead dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Procedural hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Renal artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (10.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Mid-Septal Pacing', 'description': 'Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart'}, {'id': 'OG001', 'title': 'RV Apical Pacing', 'description': 'Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex'}, {'id': 'OG002', 'title': 'Not Randomized', 'description': '7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.'}], 'timeFrame': 'Baseline and 24 months', 'description': 'Left ventricular ejection fraction (LVEF) will be measured at baseline and two year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from baseline to two year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data required for the analysis were not collected due to early study termination. Analysis will not be done.'}, {'type': 'SECONDARY', 'title': 'The Change in LVEF From Two Week Visit to Two Year Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Mid-Septal Pacing', 'description': 'Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart'}, {'id': 'OG001', 'title': 'RV Apical Pacing', 'description': 'Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex'}, {'id': 'OG002', 'title': 'Not Randomized', 'description': '7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.'}], 'timeFrame': 'Baseline and 24 months', 'description': 'Left ventricular ejection fraction (LVEF) will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data required for the analysis were not collected due to early study termination. Analysis will not be done.'}, {'type': 'SECONDARY', 'title': 'The Change in Six-minute Hall Walk Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Mid-Septal Pacing', 'description': 'Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart'}, {'id': 'OG001', 'title': 'RV Apical Pacing', 'description': 'Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex'}, {'id': 'OG002', 'title': 'Not Randomized', 'description': '7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.'}], 'timeFrame': 'Baseline and 24 months', 'description': 'The change in six-minute hall walk distance will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in six-minute hall walk distance will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in six-minute hall walk distance.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data required for the analysis were not collected due to early study termination. Analysis will not be done.'}, {'type': 'SECONDARY', 'title': 'The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Mid-Septal Pacing', 'description': 'Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart'}, {'id': 'OG001', 'title': 'RV Apical Pacing', 'description': 'Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex'}, {'id': 'OG002', 'title': 'Not Randomized', 'description': '7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.'}], 'timeFrame': 'Baseline and 24 months', 'description': 'LV end systolic volume (diastolic volume)will be measured at baseline and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LV end systolic volume (diastolic volume)from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LV end systolic volume (diastolic volume).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data required for the analysis were not collected due to early study termination. Analysis will not be done.'}, {'type': 'SECONDARY', 'title': 'Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Mid-Septal Pacing', 'description': 'Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart'}, {'id': 'OG001', 'title': 'RV Apical Pacing', 'description': 'Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex'}, {'id': 'OG002', 'title': 'Not Randomized', 'description': '7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.'}], 'timeFrame': 'Baseline and 24 months', 'description': 'Clinical event (AT/AF pnly or composite of worsening of heart failure, stroke or death) rate from baseline to two year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event rate.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data required for the analysis were not collected due to early study termination. Analysis will not be done.'}, {'type': 'SECONDARY', 'title': 'Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RV Mid-Septal Pacing', 'description': 'Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart'}, {'id': 'OG001', 'title': 'RV Apical Pacing', 'description': 'Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex'}, {'id': 'OG002', 'title': 'Not Randomized', 'description': '7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.'}], 'timeFrame': 'Baseline and 24 months', 'description': 'Clinical event (composite of worsening of heart failure, stroke or death) rate from baseline to 2 year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event(composite of worsening of heart failure, stroke or death)rate.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data required for the analysis were not collected due to early study termination. Analysis will not be done.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RV Mid-Septal Pacing', 'description': 'Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart'}, {'id': 'FG001', 'title': 'RV Apical Pacing', 'description': 'Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex'}, {'id': 'FG002', 'title': 'Not Randomized', 'description': '7 of the 205 subjects did not meet inclusion/exclusion criteria.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Data required for analysis was not collected due to early termination. Analysis will not be done.', 'groupId': 'FG000', 'numSubjects': '98'}, {'comment': 'Data required for analysis was not collected due to early termination. Analysis will not be done.', 'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Data required for analysis was not collected due to early termination. Analysis will not be done.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Data required for analysis was not collected due to early termination. Analysis will not be done.', 'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'The study was terminated early.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Enrollments in the Optimize RV trial began in March of 2007. The study was terminated early on March 26, 2009 after 205 subjects had been enrolled.', 'preAssignmentDetails': 'Seven subjects did not meet inclusion/exclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'RV Mid-Septal Pacing', 'description': 'Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart'}, {'id': 'BG001', 'title': 'RV Apical Pacing', 'description': 'Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex'}, {'id': 'BG002', 'title': 'Not Randomized', 'description': '7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '77.1', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '77.1', 'spread': '10.5', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data were not submitted due to not meeting in/exclusion criteria', 'groupId': 'BG002'}, {'value': '77.1', 'spread': '10.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'The data were not submitted due to not meeting in/exclusion criteria', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'The data were not submitted due to not meeting in/exclusion criteria', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], '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': 205}}, 'statusModule': {'whyStopped': 'Study enrollment significantly below protocol expectations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-24', 'studyFirstSubmitDate': '2007-01-12', 'resultsFirstSubmitDate': '2011-06-09', 'studyFirstSubmitQcDate': '2007-01-12', 'lastUpdatePostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-03', 'studyFirstPostDateStruct': {'date': '2007-01-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up', 'timeFrame': 'Baseline and 24 months', 'description': 'Left ventricular ejection fraction (LVEF) will be measured at baseline and two year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from baseline to two year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.'}], 'secondaryOutcomes': [{'measure': 'The Change in LVEF From Two Week Visit to Two Year Follow-up', 'timeFrame': 'Baseline and 24 months', 'description': 'Left ventricular ejection fraction (LVEF) will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.'}, {'measure': 'The Change in Six-minute Hall Walk Distance', 'timeFrame': 'Baseline and 24 months', 'description': 'The change in six-minute hall walk distance will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in six-minute hall walk distance will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in six-minute hall walk distance.'}, {'measure': 'The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up', 'timeFrame': 'Baseline and 24 months', 'description': 'LV end systolic volume (diastolic volume)will be measured at baseline and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LV end systolic volume (diastolic volume)from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LV end systolic volume (diastolic volume).'}, {'measure': 'Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up', 'timeFrame': 'Baseline and 24 months', 'description': 'Clinical event (AT/AF pnly or composite of worsening of heart failure, stroke or death) rate from baseline to two year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event rate.'}, {'measure': 'Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up', 'timeFrame': 'Baseline and 24 months', 'description': 'Clinical event (composite of worsening of heart failure, stroke or death) rate from baseline to 2 year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event(composite of worsening of heart failure, stroke or death)rate.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pacemaker', 'Implantable Pulse Generator (IPG)', 'AV Conduction Disturbance', 'Select Site Pacing'], 'conditions': ['Cardiac Pacing, Artificial', 'Cardiac Pacemaker, Artificial']}, 'descriptionModule': {'briefSummary': 'The purpose of the Optimize RV study is to determine the long-term effect of selective site pacing. Selective site pacing refers to which area of the right ventricle the lead is placed. The goal of select site pacing is to improve how the heart contracts when paced in the ventricle. By pacing in select sites, it is possible to better copy the natural pattern of contraction of the heart.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects that are expected to be paced in the right ventricle (RV) greater than 90 percent of the time\n* Subjects with an ejection fraction of greater than 40 percent within 3 months prior to enrollment\n* Subjects greater than 18 yrs of age\n* Subjects that are indicated for a dual chamber pacemaker\n* Subjects that will be implanted with a market released dual chamber Medtronic pacemaker and 3830 SelectSecure Lead in the ventricle\n\nExclusion Criteria:\n\n* Subjects indicated for cardiac resynchronization therapy (CRT) device (based on American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines)\n* Subjects indicated for an implantable cardiac defibrillator (ICD)\n* Subjects with permanent atrial fibrillation (AF)\n* Subjects with expected managed ventricular pacing turned on\n* Subjects with a previously implanted pacemaker, ICD, or CRT device\n* Subjects with an myocardial infarction (MI) within 3 months prior to enrollment\n* Subjects that received bypass surgery within 3 months prior to enrollment\n* Subjects that had valve replacement within 3 months prior to enrollment\n* Subjects where a RV lead cannot be placed, (i.e., complex congenital heart disease\n* Subjects with a mechanical right heart valve\n* Women who are pregnant or nursing\n* Significant co-morbidity preventing study completion\n* Terminal conditions with a life expectancy of less than two years\n* Participation in another study that would confound the results of this study'}, 'identificationModule': {'nctId': 'NCT00422669', 'briefTitle': 'Optimize RV Selective Site Pacing Clinical Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'Optimize RV Selective Site Pacing Clinical Trial', 'orgStudyIdInfo': {'id': '604'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RV Mid-Septal Pacing', 'description': 'Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart', 'interventionNames': ['Device: Medtronic Dual-Chamber Pacemaker', 'Device: Medtronic SelectSecure 3830 Lead']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RV Apical Pacing', 'description': 'Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex', 'interventionNames': ['Device: Medtronic Dual-Chamber Pacemaker', 'Device: Medtronic SelectSecure 3830 Lead']}], 'interventions': [{'name': 'Medtronic Dual-Chamber Pacemaker', 'type': 'DEVICE', 'description': 'A Medtronic market-approved dual-chamber implantable pulse generator (IPG)', 'armGroupLabels': ['RV Apical Pacing', 'RV Mid-Septal Pacing']}, {'name': 'Medtronic SelectSecure 3830 Lead', 'type': 'DEVICE', 'description': 'Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead', 'armGroupLabels': ['RV Apical Pacing', 'RV Mid-Septal Pacing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'Hudson', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.36445, 'lon': -82.69343}}, {'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'city': 'Silver Spring', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.99067, 'lon': -77.02609}}, {'city': 'Takoma Park', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.97789, 'lon': -77.00748}}, {'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'city': 'Montreal', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Hong Kong', 'country': 'China', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Ramat Gan', 'country': 'Israel', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'city': 'Florence', 'country': 'Italy', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Rovigo', 'country': 'Italy', 'geoPoint': {'lat': 45.06982, 'lon': 11.79022}}, {'city': 'Doha', 'country': 'Qatar', 'geoPoint': {'lat': 25.28545, 'lon': 51.53096}}], 'overallOfficials': [{'name': 'Optimize RV Team', 'role': 'STUDY_CHAIR', 'affiliation': 'Medtronic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}