Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-02-20 @ 8:08 PM
Study NCT ID:
NCT02186704
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2014-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensing Atrial High Rate Episodes With Implantable Cardioverter-Defibrillators Trial (The SENSE Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017147', 'term': 'Defibrillators, Implantable'}], 'ancestors': [{'id': 'D047548', 'term': 'Defibrillators'}, {'id': 'D004566', 'term': 'Electrodes'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D004567', 'term': 'Electrodes, Implanted'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-27', 'studyFirstSubmitDate': '2014-07-07', 'studyFirstSubmitQcDate': '2014-07-09', 'lastUpdatePostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Atrial High Rate Episode > 6 Minutes (DX System)', 'timeFrame': '1 year', 'description': 'Detection of AHRE \\> 6 minutes duration by DX lead system'}], 'primaryOutcomes': [{'measure': 'Atrial High Rate Episode', 'timeFrame': '1 year', 'description': 'Atrial high rate episode \\> 30 seconds in duration'}], 'secondaryOutcomes': [{'measure': 'Atrial Sensing (DX System)', 'timeFrame': '1 year', 'description': 'P wave amplitudes measured by DX lead system'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Implantable Defibrillators', 'Implanted Electrodes'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The primary aim of the "Sensing Atrial High Rate Episodes with DX System in Implantable Cardioverter Defibrillators Trial" (SENSE Trial) is to assess the efficacy of a implantable cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles in detecting atrial high rate episodes.\n\nThe study hypothesis is that an ICD system with a lead with dedicated atrial sensing dipoles will have a diagnostic yield comparable to that of a standard dual chamber ICD system and superior to that of a standard single chamber ICD system.', 'detailedDescription': 'The SENSE Trial is designed to study the efficacy of the DX System in detection of atrial high rate episodes (AHREs) in subjects with no prior history of atrial fibrillation. The DX System, or "DX," consists of a Biotronik DX ICD, and the Biotronik Linox Smart S DX lead which is an FDA approved ICD system that incorporates use of an implantable cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles.\n\nThe SENSE Trial will be conducted at 8-12 U.S. sites. The lead coordinating site will be at Weill Cornell Medical College. Subjects will be followed for 1 year to assess for the primary endpoints of the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with standard indications for implantable cardioverter-defibrillator implantation and no prior history of atrial fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fulfills standard indications for ICD implantation\n* Subject or legally authorized representative can provide written authorization per institutional requirements\n* Subject is intended to be implanted with a complete Biotronik DX system (consisting of a Biotronik Ilesto 7 VR-T DX ICD or any future FDA approved Lumax VR-T DX ICD, and the Biotronik Linox Smart S DX lead), or has been implanted with a complete Biotronik DX system no more than 30 days prior to the date of consent\n* Able to comply with Home Monitoring\n\nExclusion Criteria:\n\n* Subject has prior diagnosis of atrial fibrillation or atrial flutter\n* Subject has need for atrial pacing\n* Subject unwilling or unable to give informed consent or participate in follow-up\n* Subject is unable to comply with Home Monitoring\n* Subject is pregnant\n* Subject has less than one year estimated life expectancy\n* Subject was implanted with a cardiac device capable of detecting AHREs prior to implantation of the Biotronik DX system\n* Subject was implanted with Biotronik DX system and had an AHRE detection before enrollment'}, 'identificationModule': {'nctId': 'NCT02186704', 'acronym': 'SENSE', 'briefTitle': 'Sensing Atrial High Rate Episodes With Implantable Cardioverter-Defibrillators Trial (The SENSE Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Sensing Atrial High Rate Episodes With DX System in Implantable Cardioverter Defibrillators Trial', 'orgStudyIdInfo': {'id': '1401014661'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ICD with DX system', 'description': 'Implantable cardioverter-defibrillator recipients with DX system', 'interventionNames': ['Device: ICD with DX system']}, {'label': 'Dual chamber ICD', 'description': 'Dual chamber implantable-cardioverter-defibrillator recipients (retrospective cohort from IMPACT study)'}, {'label': 'Single chamber ICD', 'description': 'Single chamber implantable cardioverter-defibrillator recipients (retrospective cohort from Cornell registry)'}], 'interventions': [{'name': 'ICD with DX system', 'type': 'DEVICE', 'otherNames': ['Biotronik Ilesto 7 VR-T ICD', 'Biotronik Lumax Smart S DX ICD lead', 'Future FDA-approved Biotronik DX-capable ICD and leads'], 'description': 'Implantable cardioverter defibrillator (ICD) system implantation with single lead with ventricular sensing and pacing and defibrillation combined with dedicated atrial sensing dipole.', 'armGroupLabels': ['ICD with DX system']}]}, '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': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10532', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'Westchester Medical Center', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State Wexner University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43615', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Promedica Heart and Vascular Institute', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Einstein Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'George Thomas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biotronik, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}