Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-05 @ 5:35 PM
Study NCT ID:
NCT06578104
Status:
RECRUITING
Last Update Posted:
2025-11-14
First Post:
2024-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PULSED AF Post-Approval Study
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 580}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2024-08-27', 'studyFirstSubmitQcDate': '2024-08-27', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy-Freedom from Atrial Fibrillation', 'timeFrame': '36-months after the index ablation procedure', 'description': 'Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system.'}, {'measure': 'Safety- Freedom from Device/Procedure Related Adverse Events', 'timeFrame': '6 months post-ablation]', 'description': 'Estimate the rate of major procedural complications for catheter ablation using PulseSelect™ PFA system.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.', 'detailedDescription': 'PulseSelect is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months. Study visits will occur at 3, 6, 12, 24, and 36 months post-ablation, including required 24-hour Holter monitoring at 6, 12, 24, and 36 month visits. The PulseSelect™ PFA System used in this study is market approved and the ablation procedure will be performed according to hospital standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects 18 years or older with a planned procedure using commercially available PulseSelect™ PFA System', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF\n* Refractory to at least one Class I or III antiarrhythmic drug (i.e., not effective, not tolerated, or not desired)\n* Patient is ≥ 18 years of age\n* Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System\n* Willing and able to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements\n\nExclusion Criteria\n\n* Long-standing persistent AF (continuous AF sustained \\>12 months)\n* Prior left atrial catheter or surgical ablation\n* Patient with life expectancy \\< 36 months\n* Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)\n* Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager"}, 'identificationModule': {'nctId': 'NCT06578104', 'briefTitle': 'PULSED AF Post-Approval Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Ablation Solutions'}, 'officialTitle': 'PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry', 'orgStudyIdInfo': {'id': 'PULSED AF PAS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Paroxysmal', 'description': 'Ablation using the PulseSelect™ PFA system', 'interventionNames': ['Device: PulseSelect™ PFA system']}, {'label': 'Persistent', 'description': 'Ablation using the PulseSelect™ PFA system', 'interventionNames': ['Device: PulseSelect™ PFA system']}], 'interventions': [{'name': 'PulseSelect™ PFA system', 'type': 'DEVICE', 'description': 'Ablation using the PulseSelect™ PFA system', 'armGroupLabels': ['Paroxysmal', 'Persistent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41858-7428', 'city': 'Whitesburg', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joseph Souza, MD', 'role': 'CONTACT', 'email': 'joseph.souza@pikevillehospital.org', 'phone': '(828) 274-6000'}], 'facility': 'Pikeville Medical Center', 'geoPoint': {'lat': 37.11843, 'lon': -82.82683}}, {'zip': '02720', 'city': 'Fall River', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nitesh Sood, MD', 'role': 'CONTACT', 'email': 'soodn@southcoast.org', 'phoneExt': '(508) 973-7328'}], 'facility': 'Southcoast Health System', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ilana Kutinsky', 'role': 'CONTACT', 'email': 'ikutinsky@mhgpc.com', 'phone': '(248) 267-5050'}], 'facility': 'Beaumont Health System', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jason Payne, MD', 'role': 'CONTACT', 'email': 'jason.payne@unmc.edu'}], 'facility': 'Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10025', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Suneet Mittal, MD', 'role': 'CONTACT', 'email': 'mittsu@valleyhealth.com', 'phone': '(201) 432-7837'}], 'facility': 'The Valley Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stavros Mountantonakis, MD', 'role': 'CONTACT', 'email': 'smountanto@northwell.edu', 'phone': '(212) 434-6500'}], 'facility': 'Northwell Health Lenox Hill Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gaurang Gandhi, MD', 'role': 'CONTACT', 'email': 'gaurang_gandhi@trihealth.com', 'phone': '5137459800'}], 'facility': 'Bethesda North Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '045218', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Hummel', 'role': 'CONTACT', 'email': 'john.hummel@osumc.edu', 'phone': '(614) 293-4967'}], 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43123', 'city': 'Grove City', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jianqing Li, MD', 'role': 'CONTACT', 'email': 'jianqing.li@mchs.com', 'phone': '(614) 627-2000'}], 'facility': 'Mount Carmel Grove City Medical Center', 'geoPoint': {'lat': 39.88145, 'lon': -83.09296}}, {'zip': '18901-2554', 'city': 'Doylestown', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert Sangrigoli, MD', 'role': 'CONTACT', 'email': 'rsangrigoli@dh.org', 'phone': '267-893-6800'}], 'facility': 'Doylestown Health Cardiology a division of Doylestown Health Physicians', 'geoPoint': {'lat': 40.31011, 'lon': -75.12989}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rick Henderson, MD', 'role': 'CONTACT', 'email': 'rick.henderson1@anmedhealth.org', 'phone': '(336) 716-8636'}], 'facility': 'AnMed Health Center', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '29425-8908', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Kaplan, MD', 'role': 'CONTACT', 'email': 'kaplanra@musc.edu', 'phone': '(843) 792-2300'}], 'facility': 'Medical University of South Carolina (MUSC)', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75231-3815', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Charles Lampe, MD', 'role': 'CONTACT', 'email': 'charleslampe@texashealth.org', 'phone': '(214) 915-0507'}], 'facility': 'Texas Health Research & Education Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Mangrum, MD', 'role': 'CONTACT', 'email': 'jmm5v@virginia.edu', 'phone': '(434) 924-3817'}], 'facility': 'University of Virginia Medical Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Josman Suri', 'role': 'CONTACT', 'email': 'josman.suri@medtronic.com', 'phone': '7635050262'}], 'overallOfficials': [{'name': 'Khaldoun Tarakji, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medtronic CAS Chief Medical Officer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Ablation Solutions', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}