Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-02-20 @ 4:47 PM
Study NCT ID:
NCT03168659
Status:
RECRUITING
Last Update Posted:
2024-08-20
First Post:
2017-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CardioFocus HeartLight 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2017-05-24', 'studyFirstSubmitQcDate': '2017-05-25', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Chronic Effectiveness', 'timeFrame': '36 months', 'description': 'Freedom from symptomatic AF or symptomatic atypical AFL/AT'}, {'measure': 'Chronic Safety', 'timeFrame': '36 months', 'description': 'Reporting of adverse events'}, {'measure': 'Effect of Operator Experience on primary effectiveness endpoint', 'timeFrame': '36 months', 'description': 'Assess relationship between operator experience and freedom from symptomatic AF or symptomatic atypical AFL/AT'}, {'measure': 'Effect of Operator Experience on primary safety endpoint', 'timeFrame': '36 months', 'description': 'Assess relationship between operator experience and rate of Primary Adverse Events (PAE)'}, {'measure': 'Safety Outcomes by Gender', 'timeFrame': '12 months and 36 months', 'description': 'Assess relationship between gender and rate of PAEs'}, {'measure': 'Neurological Events', 'timeFrame': '36 months', 'description': 'Assess relationship between neurological events and procedural parameters'}], 'primaryOutcomes': [{'measure': 'The proportion of participants free from symptomatic atrial fibrillation (AF) or symptomatic atypical atrial flutter/atrial tachycardia (AFL/AT) lasting longer than 30 seconds post the 90 day blanking period', 'timeFrame': 'Day 91 through 12 months', 'description': 'The outcome will be assessed from 91 days post procedure through 12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This is a post-approval study to evaluate the clinical outcomes in a cohort of participants treated during commercial use of the HeartLight System to confirm results of the previously conducted pivotal clinical study.', 'detailedDescription': 'This is a prospective, open-label, multi-center, single arm study designed to assess continued safety and effectiveness of the HeartLight System during commercial use in participants being treated for drug refractory, symptomatic, paroxysmal atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation\n* failure of at least one anti-arrhythmic drug\n* others\n\nExclusion Criteria:\n\n* overall good health as established by multiple criteria'}, 'identificationModule': {'nctId': 'NCT03168659', 'briefTitle': 'CardioFocus HeartLight Post-Approval Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'CardioFocus'}, 'officialTitle': 'Post-Approval Study of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation', 'orgStudyIdInfo': {'id': '25-3944'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment', 'description': 'Pulmonary vein isolation ablation with HeartLight Endoscopic Ablation System', 'interventionNames': ['Device: HeartLight', 'Procedure: Ablation']}], 'interventions': [{'name': 'HeartLight', 'type': 'DEVICE', 'description': 'HeartLight Endoscopic Ablation System', 'armGroupLabels': ['Treatment']}, {'name': 'Ablation', 'type': 'PROCEDURE', 'description': 'Pulmonary vein isolation ablation', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mathew Hutchinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Arizona Sarver HeartCenter', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erik Wissner, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Illinois', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Betsy Ellsworth, MSN, ANP', 'role': 'CONTACT', 'email': 'betsy.ellsworth@mountsinai.org'}, {'name': 'Srini Dukkipati, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary Jane Strickland', 'role': 'CONTACT', 'email': 'MJS7W@hscmail.mcc.virginia.edu', 'phone': '434-982-6401'}, {'name': 'J. Michael Mangrum, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'lhausmann@cardiofocus.com', 'phone': '508-658-7253'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CardioFocus', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}