Trials / Not Yet Recruiting
Not Yet RecruitingNCT07523750
A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation
Comparison of Safety and Effectiveness of a VARIPULSE™ PFA Catheter to FARAWAVE™ PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation: A Randomized Controlled Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 466 (estimated)
- Sponsor
- Biosense Webster, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VARIPULSE Catheter | Pulsed Field Ablation using the VARIPULSE catheter. |
| DEVICE | FARAWAVE Catheter | Pulsed field ablation using the FARAWAVE catheter. |
Timeline
- Start date
- 2026-04-06
- Primary completion
- 2028-05-31
- Completion
- 2028-05-31
- First posted
- 2026-04-13
- Last updated
- 2026-04-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07523750. Inclusion in this directory is not an endorsement.