Trials / Completed
CompletedNCT04612244
The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation
A Prospective Randomized Pivotal Trial of the FARAPULSE Pulsed Field Ablation System Compared With Standard of Care Ablation in Patients With Paroxysmal Atrial Fibrillation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 706 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, adaptive, multi-center, randomized safety and effectiveness pivotal study comparing the FARAPULSE Pulsed Field Ablation System with standard of care ablation with force-sensing RF catheters and cryoballoon catheters indicated for the treatment of PAF.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FARAPULSE Pulsed Field Ablation System | Ablation using the FARAPULSE Pulsed Field Ablation System |
| DEVICE | RadioFrequency and Cryoballoon Ablation | Contact Force Enabled RF and Cryoballoon ablation catheters indicated for Paroxysmal Atrial Fibrillation |
Timeline
- Start date
- 2021-03-01
- Primary completion
- 2023-05-15
- Completion
- 2023-05-15
- First posted
- 2020-11-02
- Last updated
- 2024-11-20
- Results posted
- 2024-11-20
Locations
34 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04612244. Inclusion in this directory is not an endorsement.