Trials / Active Not Recruiting
Active Not RecruitingNCT06431815
ADVENT Post Approval Study
Prospective, Multi-site Safety and Effectiveness Post-Approval Study of FARAPULSE Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 228 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.
Detailed description
The objective of ADVENT PAS is to evaluate the long-term safety and effectiveness profile of the FARAPULSE Pulsed Field Ablation System when used to perform pulmonary vein isolation (PVI) in the de-novo ablation treatment of patients with paroxysmal atrial fibrillation (PAF).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FARAPULSE™ Pulsed Field Ablation System | De-novo pulmonary vein isolation (PVI) will be performed with the FARAPULSE Pulsed Field Ablation (PFA) System. |
Timeline
- Start date
- 2024-09-25
- Primary completion
- 2028-10-01
- Completion
- 2029-10-01
- First posted
- 2024-05-29
- Last updated
- 2026-03-31
Locations
30 sites across 4 countries: United States, Brazil, Canada, Chile
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06431815. Inclusion in this directory is not an endorsement.