Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-28 @ 7:04 PM
Study NCT ID:
NCT00930904
Status:
COMPLETED
Last Update Posted:
2017-12-27
First Post:
2009-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Model 4196 Left Ventricular (LV) Lead Chronic Performance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1847}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-22', 'studyFirstSubmitDate': '2009-06-30', 'studyFirstSubmitQcDate': '2009-06-30', 'lastUpdatePostDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lead-related complication rate', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Types of lead-related events', 'timeFrame': '5 years'}, {'measure': 'Percent of subjects with changes in electrode programming', 'timeFrame': '5 Years'}, {'measure': 'Percent of fractures with loss of function', 'timeFrame': '5 years'}, {'measure': 'Mean bipolar pacing threshold', 'timeFrame': '1 year'}, {'measure': 'Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate long-term performance of the 4196 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4196 LV Lead and is integrated within the Product Surveillance Registry (PAN Registry).', 'detailedDescription': 'Model 4196 LV lead complication-free survivability will be summarized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients implanted with a 4196 LV Lead within the past 30 days. All patients must meet Inclusion criteria and none of the Exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.\n\nInclusion Criteria\n\n* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements\n* Patient has or is intended to receive an Attain Ability Model 4196 LV lead\n* Patient within 30 day post implant enrollment window\n\nExclusion Criteria\n\n* Patient who is, or is expected to be inaccessible for follow-up\n* Patient with exclusion criteria required by local law\n* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results'}, 'identificationModule': {'nctId': 'NCT00930904', 'briefTitle': 'Model 4196 Left Ventricular (LV) Lead Chronic Performance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic'}, 'officialTitle': 'Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Post Approval Study', 'orgStudyIdInfo': {'id': '4196 Chronic Performance'}}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 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{'city': 'Reggio Emilia', 'country': 'Italy', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'city': 'Udine', 'country': 'Italy', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': '4196 LV Lead Chronic Performance Study Team', 'role': 'STUDY_CHAIR', 'affiliation': 'Medtronic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}