Trials / Recruiting
RecruitingNCT07187115
A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation
A Global Randomized Trial Comparing Pulsed Field Ablation of Pulmonary Veins Plus Extra-PV Sources Utilizing Electrographic Flow Mapping Versus Pulmonary Veins Plus Posterior Wall in Persistent Atrial Fibrillation Patients.
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 699 (estimated)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources) and to demonstrate its non-inferiority in effectiveness compared to PFA of Pulmonary Veins and LA Posterior Wall (PVI+ PWA) in the treatment of de novo symptomatic drug-refractory persistent atrial fibrillation (PersAF).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FARAPOINT Pulsed Field Ablation System | A component of the FARAPULSE Pulsed Field Ablation (PFA) System and is a multi-electrode bidirectional, deflectable percutaneous catheter, an adjunctive catheter designed to create focal-type lesions for the creation of an ablation line between the inferior vena cava and the tricuspid valve. |
| DEVICE | OptiMap System (non-ablative) | An electrophysiology mapping system that uses a proprietary algorithm to analyze electrogram signals. |
| DEVICE | FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System | All subjects will undergo electroanatomical mapping of the entire left atrium with the FARAWAVE NAV Catheter and Opal HDx Mapping System, followed by PFA PVI with the FARAWAVE NAV PFA Catheter, per the instructions of use. |
Timeline
- Start date
- 2025-11-07
- Primary completion
- 2028-07-01
- Completion
- 2030-12-01
- First posted
- 2025-09-22
- Last updated
- 2026-03-31
Locations
37 sites across 6 countries: United States, Belgium, France, Germany, Netherlands, Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07187115. Inclusion in this directory is not an endorsement.