Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT04496518
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-20
First Post:
2020-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2200}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2020-07-29', 'studyFirstSubmitQcDate': '2020-07-29', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To demonstrate the success rate of iATP in the fast VT (FVT) zone is greater than 60%', 'timeFrame': 'Approximately 5 years', 'description': 'Demonstrating success rate of iATP'}], 'secondaryOutcomes': [{'measure': 'To demonstrate the success rate of iATP in the FVT zone is greater than 70%', 'timeFrame': 'Approximately 5 years', 'description': 'Demonstrating success rate of iATP'}, {'measure': 'To characterize arrhythmia-related syncope events', 'timeFrame': 'Approximately 5 years', 'description': 'characterizing arrhythmia-related syncope events'}, {'measure': 'To characterize unnecessary and inappropriate shocks', 'timeFrame': 'Approximately 5 years', 'description': 'characterizing unnecessary and inappropriate shocks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Ventricular Tachycardia']}, 'descriptionModule': {'briefSummary': "Medtronic is sponsoring the Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS) to further confirm safety and effectiveness of ventricular iATP therapy in routine clinical practice, following commercial release of iATP-capable devices.\n\nThe iATP PAS is conducted within Medtronic's Product Surveillance Registry platform (NCT01524276).", 'detailedDescription': 'The iATP PAS is a global, prospective, observational, multi-site registry study. Patients enrolled in the iATP PAS will be prospectively followed in the registry until registry closure, patient death, or patient exit from the registry (i.e., withdrawal of consent).\n\nPatient and device status will be assessed at least annually or as prompted by reportable adverse events. Remote device data transmissions are recommended to occur at least quarterly. Primary objective analysis will occur when 241 iATP-treated eligible ventricular episodes in the fast ventricular tachycardia (FVT) zone have been collected and reviewed by the study episode review committee (ERC). The total study duration is approximately 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All patients providing informed consent to participate prior to or within 30 days of implant of an iATP-capable cardiac rhythm device with iATP on in at least one zone. Patients need to be enrolled in Medtronic's CareLink network for remote device monitoring.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements\n* Patient is intended to receive or is implanted with an iATP-capable device with iATP on in any zone with ventricular ATP therapies programmed.\n* Patient is enrolled in the CareLink network for remote device monitoring\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': 'NCT04496518', 'briefTitle': 'Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic'}, 'officialTitle': 'Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)', 'orgStudyIdInfo': {'id': 'iATP PAS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with ICD/CRT device with iATP programmed on', 'description': 'Patients implanted with an iATP-capable device with iATP on in at least one device detection zone will be enrolled in the iATP PAS. Patients must also be enrolled in the CareLink network for remote monitoring. All patients must have provided signed informed consent.', 'interventionNames': ['Device: Intrinsic Antitachycardia Pacing (iATP) Therapy']}], 'interventions': [{'name': 'Intrinsic Antitachycardia Pacing (iATP) Therapy', 'type': 'DEVICE', 'description': 'iATP is a fully automated ATP therapy for monomorphic ventricular tachycardia (MVT).', 'armGroupLabels': ['Patients with ICD/CRT device with iATP programmed on']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85226', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southwest EP', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '72205-6202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Saint Vincent Heart Clinic Arkansas', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Chula Vista Cardiac Center', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '91405', 'city': 'Van Nuys', 'state': 'California', 'country': 'United States', 'facility': 'Cardiovascular Consultants Medical Group (Van Nuys CA)', 'geoPoint': {'lat': 34.18667, 'lon': -118.44897}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Cardiology Associates Medical Group', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Springs Cardiology', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Heart', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Heart and Vascular, PC', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33021-3552', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Heart Rhythm Solutions', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32207-8208', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Health', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32405', 'city': 'Panama City', 'state': 'Florida', 'country': 'United States', 'facility': 'Cardiovascular Institute of Northwest Florida', 'geoPoint': {'lat': 30.15946, 'lon': -85.65983}}, {'zip': '34695-6604', 'city': 'Safety Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'Heart & Vascular Institute of Florida', 'geoPoint': {'lat': 27.99085, 'lon': -82.69316}}, {'zip': '34233', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Heart Rhythm Consultants P.A. 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'facility': 'Monmouth Cardiology Associates', 'geoPoint': {'lat': 39.27762, 'lon': -74.5746}}, {'zip': '87106-4921', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Presbyterian Heart Group', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11706', 'city': 'Bay Shore', 'state': 'New York', 'country': 'United States', 'facility': 'South Shore University Hospital', 'geoPoint': {'lat': 40.7251, 'lon': -73.24539}}, {'zip': '11743', 'city': 'Huntington', 'state': 'New York', 'country': 'United States', 'facility': 'Huntington Hospital', 'geoPoint': {'lat': 40.86815, 'lon': -73.42568}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10549', 'city': 'Mount Kisco', 'state': 'New York', 'country': 'United States', 'facility': 'Northern Westchester Hospital', 'geoPoint': {'lat': 41.20426, 'lon': -73.72708}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Jewish Medical Center', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York-Presbyterian Hospital/Weill Cornell Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NewYork-Presbyterian/Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Lenox Hill Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '12601-3923', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Hudson Valley Heart Center', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': 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'United States', 'facility': 'Saint Thomas Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78705-1852', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cardiac Arrhythmia Research Foundation', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '761014', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Heart Center of North Texas', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Consultants in Cardiology (Fort Worth TX)', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '53215-3678', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Aurora Cardiovascular Services', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '84082', 'city': 'Avignon', 'country': 'France', 'facility': 'Clinique Rhône Durance', 'geoPoint': {'lat': 43.94834, 'lon': 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