Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-27 @ 5:10 AM
Study NCT ID:
NCT01485666
Status:
COMPLETED
Last Update Posted:
2022-06-24
First Post:
2011-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoratec's Reduce Driveline Trauma Through Stabilization and Exit Site Management Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-23', 'studyFirstSubmitDate': '2011-12-01', 'studyFirstSubmitQcDate': '2011-12-02', 'lastUpdatePostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demonstration of the wearability and usability of the Percutaneous Lead Management Kit', 'timeFrame': 'Up to 30 days'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse reactions to any Percutaneous Lead Management Kit components', 'timeFrame': 'Up to 6 months'}, {'measure': 'Evidence of driveline infection', 'timeFrame': 'Up to 6 months'}, {'measure': "Durability of the Percutaneous Lead Management Kit's infection mitigation and stabilization", 'timeFrame': 'Up to 7 days continuous kit use'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thoratec', 'HeartMate II', 'heart-assist devices', 'driveline or percutaneous lead management', 'HeartMate II Percutaneous Lead Management'], 'conditions': ['Left Ventricular Assist Device', 'Percutaneous Lead Management']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the feasibility of a Percutaneous Lead Management Kit for HeartMate II driveline stabilization and exit site management.', 'detailedDescription': 'The Percutaneous Lead Management Kit is a combination of commercially available components that are packaged together in a kit to be used for HeartMate II driveline exit site cleaning, dressing and stabilization. The RESIST study is a prospective, non-randomized study to evaluate the wearability and usability of the Percutaneous Lead Management Kit. Evaluation of the Percutaneous Lead Management Kit for wearability and usability will be performed for 30 days from enrollment. Study patients will also be followed for up to 6 months for any evidence of driveline infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Ventricular Assist Device clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent form\n* 16 years of age or older\n* Supported by HeartMate II LVAD continuously for at least 6 months and not currently hospitalized\n* Will continue on LVAD support for at least another 30 days\n* No driveline or systemic infection\n* Willing and able to perform kit dressing changes at least once every 7 days for 30 days\n* Can fill out study forms\n* Can use a digital camera\n* Willing to return to clinic for final study visit in 30 days\n\nExclusion Criteria:\n\n* High risk for non-compliance\n* Ongoing mechanical circulatory support other than HeartMate II LVAD\n* Sensitivity to kit components\n* Skin condition that may react to kit component adhesives\n* Already using all components of Percutaneous Lead Management Kit'}, 'identificationModule': {'nctId': 'NCT01485666', 'acronym': 'RESIST', 'briefTitle': "Thoratec's Reduce Driveline Trauma Through Stabilization and Exit Site Management Study", 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Reduce Driveline Trauma Through Stabilization and Exit Site Management (RESIST) Pilot Study Protocol', 'orgStudyIdInfo': {'id': 'TC06072011-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Percutaneous Lead Management Kit', 'type': 'OTHER', 'otherNames': ['Thoratec', 'HeartMate II'], 'description': 'A kit of commercially available components to be used for HeartMate II driveline exit site cleaning, dressing and stabilization'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Memorial Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health Systems', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Pooja Chatterjee', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Thoratec Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Thoratec Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}