Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT07227532
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 276}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-11-11', 'studyFirstSubmitQcDate': '2025-11-11', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure', 'timeFrame': 'Within 7 days post index procedure', 'description': "PAE's will include the following adverse events: atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis."}, {'measure': 'Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episodes', 'timeFrame': 'Day 61-1095 post-index procedure', 'description': 'Freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmias (atrial fibrillation \\[AF\\], atrial tachycardia \\[AT\\] or atrial flutter \\[AFL\\] of unknown origin) episodes will be reported. AFL of unknown origin is defined as all AFL except those Cavotricuspid isthmus CTI dependent AFL as confirmed by 12-Lead electrocardiogram (ECG) and entrainment maneuvers in an evaluation period study.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long-term safety and effectiveness of the VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF\n* Refractory, intolerant, or contraindicated to Class I/III antiarrhythmic drugs (AAD)\n* Willing and capable of providing consent\n* Able and willing to comply with all pre-, post-, and follow-up testing and requirements\n\nExclusion Criteria:\n\n* Previously diagnosed with persistent or long-standing persistent AF (more than \\[\\>\\] 7 days in duration)\n* Previous surgical or catheter ablation for AF\n* Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF\n* Current enrollment in an investigational study evaluating another device or drug\n* Life expectancy less than 12 months\n* Any contraindications as defined in the Protocol'}, 'identificationModule': {'nctId': 'NCT07227532', 'acronym': 'AdmIREPAS', 'briefTitle': 'A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosense Webster, Inc.'}, 'officialTitle': 'Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System', 'orgStudyIdInfo': {'id': 'BWI202405'}, 'secondaryIdInfos': [{'id': 'BWI202405', 'type': 'OTHER', 'domain': 'Biosense Webster, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator', 'description': 'Participants undergoing electrophysiology mapping and pulsed field ablation (PFA) for management of treatment of symptomatic paroxysmal atrial fibrillation (AF) will undergo pulmonary vein (PV) ablation with the VARIPULSE Catheter with a TRUPULSE Generator.', 'interventionNames': ['Device: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator']}], 'interventions': [{'name': 'Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator', 'type': 'DEVICE', 'description': 'Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.', 'armGroupLabels': ['Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93003', 'city': 'Ventura', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Community Memorial Hospital', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '53548', 'city': 'Janesville', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mercy Hospital', 'geoPoint': {'lat': 42.68279, 'lon': -89.01872}}], 'centralContacts': [{'name': 'Emily Purcell', 'role': 'CONTACT', 'email': 'EPurcel1@its.jnj.com', 'phone': '+1 949 230 3701'}], 'overallOfficials': [{'name': 'Biosense Webster, Inc. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biosense Webster, Inc.'}]}, 'ipdSharingStatementModule': {'url': 'https://innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency', 'ipdSharing': 'YES', 'description': 'The data sharing policy of Johnson \\& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biosense Webster, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}