Trials / Recruiting
RecruitingNCT07227532
A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System
Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 276 (estimated)
- Sponsor
- Biosense Webster, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator | Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used. |
Timeline
- Start date
- 2025-10-21
- Primary completion
- 2030-12-31
- Completion
- 2030-12-31
- First posted
- 2025-11-12
- Last updated
- 2026-03-17
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07227532. Inclusion in this directory is not an endorsement.