Trials / Active Not Recruiting
Active Not RecruitingNCT06099730
Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- Sponsor
- Massachusetts General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation in the treatment of subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation with the VARIPULSE™ catheter and the TRUPULSE™ generator.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pulsed Field Ablation (PFA) | PFA using Irreversible Electroporation (IRE) Ablation System |
Timeline
- Start date
- 2023-12-14
- Primary completion
- 2026-11-01
- Completion
- 2026-11-01
- First posted
- 2023-10-25
- Last updated
- 2025-05-06
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06099730. Inclusion in this directory is not an endorsement.