Trials / Completed
CompletedNCT05443594
A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 669 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the ADVANTAGE AF Study is to establish the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System (FARAPULSE PFA System) for treatment of drug resistant, symptomatic persistent atrial fibrillation (PersAF).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Phase 1: FARAPULSE Ablation System | PHASE 1: Pulsed Field Ablation to isolate the Pulmonary Veins and Posterior Wall using the FARAPULSE Ablation System. |
| DEVICE | Phase 2: FARAPULSE Ablation System | PHASE 2: Pulsed Field Ablation to isolate the Pulmonary Veins, Posterior Wall and Cavo-Tricuspid Isthmus using the FARAPULSE Ablation System. |
Timeline
- Start date
- 2023-02-28
- Primary completion
- 2025-02-11
- Completion
- 2025-02-11
- First posted
- 2022-07-05
- Last updated
- 2025-12-16
- Results posted
- 2025-10-24
Locations
44 sites across 4 countries: United States, Belgium, Canada, Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05443594. Inclusion in this directory is not an endorsement.