The ReMATCH Study is a Prospective, Single Arm, Open Label, Multi-center, Study Utilizing the FARAPULSE PFA System, Including the FARAWAVE and FARAPOINT PFA Catheters

NCT06735534 NA RECRUITING

The ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters.

Details

Lead sponsor	Boston Scientific Corporation
Phase	NA
Status	RECRUITING
Enrolment	376
Start date	2025-06-03
Completion	2028-01

Conditions

• Persistent Atrial Fibrillation

Interventions

• FARAPULSE™ Pulsed Field Ablation System

Primary outcomes

• Primary safety endpoint rate — 60 days
  The primary safety endpoint (PSE) is the proportion of Treatment subjects with one or more device or procedure-related Composite Serious Adverse Events (CSAEs) following the Repeat Ablation Procedure.
• The primary effectiveness endpoint is the proportion of Treatment subjects with Acute Procedural Success. — 24 hours
  The proportion of Treatment Subjects with confirmed electrical block across all anatomical locations ablated with the investigational system only (Acute Procedural Success).

Countries

United States, Australia, Taiwan