NCT07227532Recruiting
A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System
BWI202405: Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 276 (estimated)
- First submitted
- 11 Nov 2025
- Start date
- 21 Oct 2025
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Biosense Webster, Inc.
- Diseases
- Atrial fibrillation
- NCT number
- NCT07227532
What you commit to
- Study type: Interventional
- Planned participants: 276
- From 21 Oct 2025 to the primary completion date, 31 Dec 2030
- 25 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously diagnosed with persistent or long-standing persistent AF (more than \[\>\] 7 days in duration)
- Previous surgical or catheter ablation for AF
- Current enrollment in an investigational study evaluating another device or drug
Other
- Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF
- Life expectancy less than 12 months
- Any contraindications as defined in the Protocol
Who the study is looking for
- Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF
- Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD)
- Willing and capable of providing consent
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aurora Denver Cardiology Associates Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Texas Cardiac Arrhythmia Research Foundation Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| The Christ Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Baylor Scott and White Research Institute Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| OC Memorial Coordinator of this site? Confirm its status | Fountain Valley | United States | Recruiting |
| University of Iowa Hospitals and Clinics Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Mercy Hospital Coordinator of this site? Confirm its status | Janesville | United States | Recruiting |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Northwell Health Physician Partners Cardiology Coordinator of this site? Confirm its status | Lake Success | United States | Recruiting |
| HCA Florida Mercy Hospital Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Edward Hospital Midwest Cardiovascular Institute Coordinator of this site? Confirm its status | Naperville | United States | Recruiting |
| Orlando Health Heart and Vascular Institute Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| The Kansas City Heart Rhythm Institute Coordinator of this site? Confirm its status | Overland Park | United States | Recruiting |
| Phoenix Cardiovascular Research Group Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano Coordinator of this site? Confirm its status | Plano | United States | Recruiting |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Springfield Medical Center Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Albert Einstein College of Medicine - Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Capital Health Regional Medical Center Coordinator of this site? Confirm its status | Trenton | United States | Recruiting |
| Tucson Medical Center Pima Heart and Vascular Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
| Community Memorial Hospital Coordinator of this site? Confirm its status | Ventura | United States | Recruiting |
| Winchester Medical Center Coordinator of this site? Confirm its status | Winchester | United States | Recruiting |
| Trinity Health Coordinator of this site? Confirm its status | Ypsilanti | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.