Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-30 @ 1:44 AM
Study NCT ID:
NCT00853593
Status:
COMPLETED
Last Update Posted:
2019-02-18
First Post:
2009-02-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Model 4396 Left Ventricular (LV) Lead Study
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': 'medtronicCRMtrials@medtronic.com', 'phone': '800-328-2518', 'title': '4396 Clinical Research Specialist', 'phoneExt': '62808', 'organization': 'Medtronic, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Subject enrollment-exit', 'description': 'Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function', 'eventGroups': [{'id': 'EG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects successfully implanted with a Model 4396 LV lead.', 'otherNumAtRisk': 197, 'otherNumAffected': 27, 'seriousNumAtRisk': 197, 'seriousNumAffected': 76}], 'otherEvents': [{'term': 'Inappropriate phrenic nerve stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Inappropriate stimulation of diaphragm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'seriousEvents': [{'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Alcoholic withdrawal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Aneurysm of aortic arch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Asystole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial fibrillation with rapid ventricular response', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Central line infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Chest tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'COPD exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Coronary artery disease aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Decompensated heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Cardiac disorders'}, {'term': 'Deep venous thrombosis arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Degenerative joint disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Device lead issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Effusion pleural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Elevated pacing threshold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Embolism pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Embolus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Femoral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Fever of unknown origin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Foot infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Gastrointestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'GI bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gouty arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Herniated disc', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders'}, {'term': 'Implant site hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Implant site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Inadequate lead connection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Inappropriate phrenic nerve stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Insulin hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Intracerebral hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Laceration of head', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Lead dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Loss of capture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Loss of control of diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Middle cerebral artery stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Multiple organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Near syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Non ST segment elevation myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Peripheral vascular disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Prostatic hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Small bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Transient ischemic attack (TIA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Triple vessel disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': "Twiddler's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Uncontrolled hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety (Subjects Without a Model 4396 Lead Related Complication)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects who underwent a Model 4396 left ventricular lead implant attempt'}], 'classes': [{'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000', 'lowerLimit': '90.6', 'upperLimit': '95'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'One sample proportion', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '.951', 'ciLowerLimit': '.906', 'estimateComment': 'The Model 4396 lead will be considered safe if the proportion of subjects free of Model 4396 lead-related complications at one month post-implant is greater than 80% (i.e. the one sided 95% lower confidence bound must be at least 80%).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'One month', 'description': "A subject who was free of a Model 4396 lead related complication by the one month visit. All adverse events (AE) in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee (AEAC). The AEAC determined whether an AE was a complication and whether the event was related to the Model 4396 lead. A complication is an AE that results in death, termination of significant device function or invasive intervention (any therapy that penetrates the skin including administration of intramuscular (IM) and parenteral (IV) fluids).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who underwent a Model 4396 left ventricular (LV) lead implant attempt and had a 1 month follow-up visit.'}, {'type': 'PRIMARY', 'title': 'Efficacy: Distal Tip Electrode Voltage Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects with tip electrode capture at 0.5ms at 1-month.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'One sample mean', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciUpperLimit': '1.8', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.4', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'One month', 'description': "Subjects' distal tip electrode voltage threshold was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts. Voltage threshold was collected using LV tip to Right Ventricular (RV) coil configuration at 0.5 milliseconds \\[ms\\]. Voltage threshold is the minimum energy required from the device to consistently pace the ventricle.", 'unitOfMeasure': 'Volts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with pacing thresholds captured at 0.5 ms were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Efficacy: Proximal Ring Voltage Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects with ring electrode threshold captured at 0.5ms at 3-month.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '2.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'One sample mean', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '2.3', 'ciUpperLimit': '2.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.0', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Three months', 'description': "Subject's proximal ring electrode voltage threshold was collected at the three months visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts.", 'unitOfMeasure': 'Volts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with ring electrode threshold captured at 0.5 ms at 3-month'}, {'type': 'SECONDARY', 'title': 'Subjects Successfully Implanted With Model 4396 Lead', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects successfully implanted with a Model 4396 LV lead.'}], 'classes': [{'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'One sample proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.927', 'ciLowerLimit': '.887', 'ciUpperLimit': '.967', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'During implant procedure.', 'description': 'A successful implant occurs when the Model 4396 lead is implanted in a left ventricular vein and functions appropriately. A Model 4396 implant attempt was defined as any time when a Model 4396 lead was introduced into the body.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who underwent Model 4396 LV implant attempt.'}, {'type': 'SECONDARY', 'title': 'Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Transvenous LV Lead', 'description': 'Subjects who underwent an implant attempt with successful CS cannulation.'}], 'classes': [{'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'One sample proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.969', 'ciLowerLimit': '.944', 'ciUpperLimit': '.993', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'During implant procedure.', 'description': 'A successful implant after cannulation occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead (any transvenous LV lead) is implanted in a left ventricular vein and functions appropriately. An implant attempt of any transvenous LV lead was defined as any time when a transvenous LV lead was introduced into the body.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with successful CS cannulation after an implant attempt.'}, {'type': 'SECONDARY', 'title': 'Subjects Successfully Implanted With Any Transvenous LV Lead', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Transvenous LV Lead', 'description': 'Subjects who underwent an implant attempt.'}], 'classes': [{'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'One sample proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.959', 'ciLowerLimit': '.930', 'ciUpperLimit': '.987', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'During implant procedure.', 'description': 'A successful implant occurs when any transvenous LV lead is implanted in a left ventricular vein functions appropriately.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who underwent an implant attempt.'}, {'type': 'SECONDARY', 'title': 'Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Medtronic LV Lead (Attain Family Lead)', 'description': 'Subjects who underwent an implant attempt.'}], 'classes': [{'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'One sample proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.948', 'ciLowerLimit': '.917', 'ciUpperLimit': '.979', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'During implant procedure.', 'description': 'A successful implant occurs when any Medtronic Attain Family LV Lead is implanted in a left ventricular vein and functions appropriately. The Attain Family leads include the following models: 4193, 4194, 4195, 4196, and 4396.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who underwent an implant attempt.'}, {'type': 'SECONDARY', 'title': 'Cannulation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects successfully implanted with a Model 4396 LV lead.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '9.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During implant procedure.', 'description': 'Cannulation time was defined as the time from insertion of the first coronary sinus (CS) cannulation catheter to the first successful CS cannulation.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects successfully implanted with a Model 4396 lead.'}, {'type': 'SECONDARY', 'title': 'Fluoroscopy Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects successfully implanted with a Model 4396 LV lead.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'spread': '13.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During implant procedure.', 'description': 'The total time the fluoroscope was imaging (not including biplane fluoroscopy time).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Subjects successfully implanted with a Model 4396 lead. Note that one subject's standard fluoroscopy time was not collected and a study deviation was reported."}, {'type': 'SECONDARY', 'title': 'Model 4396 Lead Placement Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects successfully implanted with a Model 4396 LV lead.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'spread': '16.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During implant procedure.', 'description': 'Model 4396 lead placement time was defined as the time from insertion of the successfully implanted lead to the time when it was placed in the first acceptable pacing location.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Subjects successfully implanted with a Model 4396 lead. Note that one subject's LV Lead placement time was permanently missing and a study deviation was reported."}, {'type': 'SECONDARY', 'title': 'Total Operation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects successfully implanted with a Model 4396 LV lead.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.4', 'spread': '41.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During implant procedure.', 'description': 'Total operation time was defined as time from initial incision to final closure.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects successfully implanted with a Model 4396 lead.'}, {'type': 'SECONDARY', 'title': 'Assessment of Lead Handling Characteristics Reported as Acceptable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Model 4396 lead implant attempts.'}], 'classes': [{'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During implant procedure.', 'description': 'Implant lead handling characteristics were qualitatively assessed through physician feedback on the Implant Case Report Form (CRF). Physicians were asked for their overall assessment of the lead and results were categorized as acceptable or unacceptable. The number of acceptable responses are summarized.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who underwent a Model 4396 left ventricular lead implant attempt.'}, {'type': 'SECONDARY', 'title': 'Efficacy: Bipolar Voltage Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects successfully implanted with a Model 4396 LV lead and completed 1 month visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '1.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'One sample mean', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciUpperLimit': '2.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.9', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': "Subjects' voltage threshold in the bipolar configuration was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold (at 0.5 milliseconds \\[ms\\]) is less than or equal to 4.0 Volts.", 'unitOfMeasure': 'Volts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects that were implanted with a Model 4396 lead and completed the 1 month visit'}, {'type': 'SECONDARY', 'title': 'Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects with tip electrode threshold captured at 0.5ms at 6 month.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': 'Tip electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold values at the 6 month visit are summarized.', 'unitOfMeasure': 'Volts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with tip electrode threshold captured at 0.5 ms at 6 month'}, {'type': 'SECONDARY', 'title': 'Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects with tip electrode pacing impedance at 6 month.'}], 'classes': [{'categories': [{'measurements': [{'value': '571.2', 'spread': '155.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': "Subjects' tip electrode pacing impedance (a measure of electrical resistance) was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.", 'unitOfMeasure': 'Ohms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with tip electrode pacing impedance at 6 month'}, {'type': 'SECONDARY', 'title': 'Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects with ring electrode R-wave amplitude at 6 month.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'spread': '6.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': 'Tip electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here. Sensing is the minimum energy produced by the left ventricle of the heart that the device can sense.', 'unitOfMeasure': 'mV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with tip electrode R-wave amplitude at 6 month'}, {'type': 'SECONDARY', 'title': 'Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects with ring electrode threshold captured at 0.5 ms at 6 month.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': 'Ring electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is presented here.', 'unitOfMeasure': 'Volts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with ring electrode threshold captured at 0.5 ms at 6 month'}, {'type': 'SECONDARY', 'title': 'Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects with ring electrode pacing impedance at 6 month.'}], 'classes': [{'categories': [{'measurements': [{'value': '544.8', 'spread': '149.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': "Subjects' ring electrode pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.", 'unitOfMeasure': 'Ohms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with ring electrode pacing impedance at 6 month'}, {'type': 'SECONDARY', 'title': 'Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects with ring electrode R-wave amplitude at implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'spread': '6.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During implant procedure.', 'description': 'Ring electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected only at the implant procedure because the devices allowed in this study are not programmable to collect sensing measurements using the ring electrode. The analyzer was used to collect measurements.', 'unitOfMeasure': 'mV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with ring electrode R-wave amplitude at implant'}, {'type': 'SECONDARY', 'title': 'Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects with bipolar configuration threshold captured at 0.5ms at 6 month.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': 'Bipolar voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is reported here.', 'unitOfMeasure': 'Volts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with bipolar configuration threshold captured at 0.5 ms at 6 month'}, {'type': 'SECONDARY', 'title': 'Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects with bipolar configuration pacing impedance at 6 month.'}], 'classes': [{'categories': [{'measurements': [{'value': '967.1', 'spread': '239.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': "Subjects' bipolar pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.", 'unitOfMeasure': 'Ohms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with bipolar configuration pacing impedance at 6 month'}, {'type': 'SECONDARY', 'title': 'Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects with bipolar configuration R-wave amplitude at 6 month.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'spread': '7.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': 'Bipolar sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here.', 'unitOfMeasure': 'mV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with bipolar configuration electrode R-wave amplitude at 6 month.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects successfully implanted with a Model 4396 LV lead.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}]}, {'type': 'Implant Attempted', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}]}, {'type': 'Model 4396 Lead Attempted', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}], 'dropWithdraws': [{'type': 'Subjects did not receive a 4396 lead', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Model 4396 lead not attempted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'Implant not attempted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Model 4396 LV Lead', 'description': 'Subjects underwent Model 4396 left ventricular lead implant attempt'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '131', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All subjects who underwent an implant attempt (193) were included in the study population analysis.', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.6', 'spread': '10.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'All subjects who underwent an implant attempt (193) were included in the study population analysis.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '140', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All subjects who underwent an implant attempt (193) were included in the study population analysis.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'All subjects who underwent an implant attempt (193) were included in the study population analysis.', 'unitOfMeasure': 'participants'}, {'title': 'New York Heart Association', 'classes': [{'title': 'Class III', 'categories': [{'measurements': [{'value': '192', 'groupId': 'BG000'}]}]}, {'title': 'Class IV', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'All subjects who underwent an implant attempt (193) were included in the study population analysis', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '168', 'groupId': 'BG000'}]}]}, {'title': 'Subject chose not to provide information', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'All subjects who underwent an implant attempt (193) were included in the study population.', 'unitOfMeasure': 'participants'}, {'title': 'Intrinsic QRS Width', 'classes': [{'categories': [{'measurements': [{'value': '154.1', 'spread': '24.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'All subjects who underwent an implant attempt (193) were included in the study population analysis.', 'unitOfMeasure': 'Milliseconds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Left Ventricular Ejection Fraction (LVEF)', 'classes': [{'categories': [{'measurements': [{'value': '25.7', 'spread': '6.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'All subjects who underwent an implant attempt (193) were included in the study population analysis. Note, one subject did not have a LVEF within 365 days of baseline and a study deviation was reported for not meeting inclusion/exclusion criteria.', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'dispFirstSubmitDate': '2010-05-27', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2009-02-26', 'dispFirstSubmitQcDate': '2010-05-27', 'resultsFirstSubmitDate': '2011-08-25', 'studyFirstSubmitQcDate': '2009-02-27', 'dispFirstPostDateStruct': {'date': '2010-06-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-10-27', 'studyFirstPostDateStruct': {'date': '2009-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety (Subjects Without a Model 4396 Lead Related Complication)', 'timeFrame': 'One month', 'description': "A subject who was free of a Model 4396 lead related complication by the one month visit. All adverse events (AE) in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee (AEAC). The AEAC determined whether an AE was a complication and whether the event was related to the Model 4396 lead. A complication is an AE that results in death, termination of significant device function or invasive intervention (any therapy that penetrates the skin including administration of intramuscular (IM) and parenteral (IV) fluids)."}, {'measure': 'Efficacy: Distal Tip Electrode Voltage Threshold', 'timeFrame': 'One month', 'description': "Subjects' distal tip electrode voltage threshold was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts. Voltage threshold was collected using LV tip to Right Ventricular (RV) coil configuration at 0.5 milliseconds \\[ms\\]. Voltage threshold is the minimum energy required from the device to consistently pace the ventricle."}, {'measure': 'Efficacy: Proximal Ring Voltage Threshold', 'timeFrame': 'Three months', 'description': "Subject's proximal ring electrode voltage threshold was collected at the three months visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts."}], 'secondaryOutcomes': [{'measure': 'Subjects Successfully Implanted With Model 4396 Lead', 'timeFrame': 'During implant procedure.', 'description': 'A successful implant occurs when the Model 4396 lead is implanted in a left ventricular vein and functions appropriately. A Model 4396 implant attempt was defined as any time when a Model 4396 lead was introduced into the body.'}, {'measure': 'Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation', 'timeFrame': 'During implant procedure.', 'description': 'A successful implant after cannulation occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead (any transvenous LV lead) is implanted in a left ventricular vein and functions appropriately. An implant attempt of any transvenous LV lead was defined as any time when a transvenous LV lead was introduced into the body.'}, {'measure': 'Subjects Successfully Implanted With Any Transvenous LV Lead', 'timeFrame': 'During implant procedure.', 'description': 'A successful implant occurs when any transvenous LV lead is implanted in a left ventricular vein functions appropriately.'}, {'measure': 'Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead', 'timeFrame': 'During implant procedure.', 'description': 'A successful implant occurs when any Medtronic Attain Family LV Lead is implanted in a left ventricular vein and functions appropriately. The Attain Family leads include the following models: 4193, 4194, 4195, 4196, and 4396.'}, {'measure': 'Cannulation Time', 'timeFrame': 'During implant procedure.', 'description': 'Cannulation time was defined as the time from insertion of the first coronary sinus (CS) cannulation catheter to the first successful CS cannulation.'}, {'measure': 'Fluoroscopy Time', 'timeFrame': 'During implant procedure.', 'description': 'The total time the fluoroscope was imaging (not including biplane fluoroscopy time).'}, {'measure': 'Model 4396 Lead Placement Time', 'timeFrame': 'During implant procedure.', 'description': 'Model 4396 lead placement time was defined as the time from insertion of the successfully implanted lead to the time when it was placed in the first acceptable pacing location.'}, {'measure': 'Total Operation Time', 'timeFrame': 'During implant procedure.', 'description': 'Total operation time was defined as time from initial incision to final closure.'}, {'measure': 'Assessment of Lead Handling Characteristics Reported as Acceptable', 'timeFrame': 'During implant procedure.', 'description': 'Implant lead handling characteristics were qualitatively assessed through physician feedback on the Implant Case Report Form (CRF). Physicians were asked for their overall assessment of the lead and results were categorized as acceptable or unacceptable. The number of acceptable responses are summarized.'}, {'measure': 'Efficacy: Bipolar Voltage Threshold', 'timeFrame': '1 month', 'description': "Subjects' voltage threshold in the bipolar configuration was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold (at 0.5 milliseconds \\[ms\\]) is less than or equal to 4.0 Volts."}, {'measure': 'Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold', 'timeFrame': '6 month', 'description': 'Tip electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold values at the 6 month visit are summarized.'}, {'measure': 'Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance', 'timeFrame': '6 month', 'description': "Subjects' tip electrode pacing impedance (a measure of electrical resistance) was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here."}, {'measure': 'Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing', 'timeFrame': '6 month', 'description': 'Tip electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here. Sensing is the minimum energy produced by the left ventricle of the heart that the device can sense.'}, {'measure': 'Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold', 'timeFrame': '6 month', 'description': 'Ring electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is presented here.'}, {'measure': 'Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance', 'timeFrame': '6 month', 'description': "Subjects' ring electrode pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here."}, {'measure': 'Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing', 'timeFrame': 'During implant procedure.', 'description': 'Ring electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected only at the implant procedure because the devices allowed in this study are not programmable to collect sensing measurements using the ring electrode. The analyzer was used to collect measurements.'}, {'measure': 'Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold', 'timeFrame': '6 month', 'description': 'Bipolar voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is reported here.'}, {'measure': 'Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance', 'timeFrame': '6 month', 'description': "Subjects' bipolar pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here."}, {'measure': 'Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing', 'timeFrame': '6 month', 'description': 'Bipolar sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heart failure', 'cardiac pacing', 'cardiac resynchronization therapy', 'left ventricular lead'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe and effective. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.', 'detailedDescription': 'This study is a prospective, multi-center, non-randomized design. All consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. The study design has statistical power to show safety at one-month after implant. It also has statistical power to show effectiveness at one-month and three-months after implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CRT/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications, New York Heart Association (NYHA) III and IV, indicated for implantable cardiac defibrillator (ICD) if CRT-D is implanted, patient consent, geographically stable\n\nExclusion Criteria:\n\n* LV lead implant attempt in last 30 days, unstable angina or acute myocardial infarction (MI) in past 30 days, coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) in past 3 months, contraindicated for transvenous pacing, heart transplant'}, 'identificationModule': {'nctId': 'NCT00853593', 'acronym': '4396', 'briefTitle': 'Model 4396 Left Ventricular (LV) Lead Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'Model 4396 Left Ventricular Lead Study', 'orgStudyIdInfo': {'id': '116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Model 4396 LV Lead', 'description': 'Non-randomized study.', 'interventionNames': ['Device: Pacing Lead']}], 'interventions': [{'name': 'Pacing Lead', 'type': 'DEVICE', 'description': 'implant and follow-up of study device', 'armGroupLabels': ['Model 4396 LV Lead']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Atlantis', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': 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'lon': 14.28611}}, {'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Aarhus', 'country': 'Denmark', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Nantes', 'country': 'France', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Toulouse', 'country': 'France', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Treviso', 'country': 'Italy', 'geoPoint': {'lat': 45.66673, 'lon': 12.2416}}, {'city': 'Riyadh', 'country': 'Saudi Arabia', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Derek Exner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Foothills Hospital (University of Calgary)'}, {'name': 'Daniel Gras, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nouvelles Cliniques Nantaises'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}