Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT01615835
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2007-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2007-12-21', 'studyFirstSubmitQcDate': '2012-06-06', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine feasibility of CS mapping with EnSite NavX during CRT implant', 'timeFrame': 'Procedural'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congestive Heart Failure']}, 'descriptionModule': {'briefSummary': 'Use of the EnSite NavX system to map the coronary vasculature during CRT implant', 'detailedDescription': 'Objective(s):\n\nTo determine the feasibility of CS mapping with NavX during Biventricular Implantable Cardioverter Defibrillator (BiV ICD) implantation.\n\nInclusion Criteria:\n\n* Subject is between the age of 18 and 75 years\n* Subject is willing and able to sign a study specific informed consent\n* Subject is able to fulfill study requirements\n* Meet the conventional criteria for implant of a BiV ICD, including; LVEF of ≤35%, QRS ≥ 120 ms and NYHA III-IV\n* Have persistent CHF symptoms despite contemporary CHF medical therapy\n* Stable and optimal medical therapy (stability is no changes in past 3 months).\n* Documented history of ischemic or non-ischemic cardiomyopathy.\n\nExclusion Criteria:\n\n* Have any standard device exclusions including tricuspid valve prosthesis/ replacement.\n* Have a positive urine or serum pregnancy test (if female and of childbearing potential)\n* Be currently participating in an IDE or IND study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet criteria for CRT implant including EF\\<35%, QRS\\>120ms, NYHA class III or IV\n* Persistent CHF symptoms despite optimization\n* Stable/optimal medical therapy\n* History of ischemic or non-ischemic cardiomyopathy\n\nExclusion Criteria:\n\n* Any standard device exclusion including TVR\n* Positive pregnancy test\n* Currently participating in IDE/IND study'}, 'identificationModule': {'nctId': 'NCT01615835', 'acronym': 'Bi-VNavX', 'briefTitle': 'EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Mapping in the Coronary Sinus During Implant of a Bi-Ventricular Implantable Cardioverter Defibrillator Utilizing the NavX Mapping System', 'orgStudyIdInfo': {'id': '067.3'}}, 'armsInterventionsModule': {'interventions': [{'name': 'EnSite NavX System', 'type': 'OTHER', 'description': 'EnSite NavX system is a 3D Mapping system'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medical College of Georgia', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Adam Berman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Augusta University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}