NCT06735534

Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 376 (estimated)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The goal of this study is to evaluate the safety and effectiveness of using the FARAWAVE™ and FARAPOINT™ pulsed field ablation (PFA) catheters for re-treatment of persistent atrial fibrillation (PersAF) after a failed initial procedure.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	FARAPULSE™ Pulsed Field Ablation System	The FARAPULSE™ Pulsed Field Ablation System is indicated for the treatment of symptomatic atrial fibrillation. The FARAWAVE Catheter is indicated for the isolation of pulmonary veins and posterior wall in the treatment of drug-refractory, recurrent, symptomatic paroxysmal and persistent atrial fibrillation. The FARAWAVE Catheter is also indicated for the for the isolation of pulmonary veins and posterior wall in the treatment of persistent atrial fibrillation as an alternative to anti-arrhythmic drug (AAD) therapy as an initial rhythm control strategy. The FARAPOINT™ PFA Catheter is indicated for use as an adjunctive device for 1) the creation of an ablation line between the inferior vena cava and the tricuspid valve and/or 2) Mitral Isthmus, when the FARAWAVE Catheter is used in the endocardial treatment of persistent atrial fibrillation (episode duration no greater than 12 months).

Timeline

• Start date: 2025-06-03
• Primary completion: 2027-04-01
• Completion: 2028-01-01
• First posted: 2024-12-16
• Last updated: 2026-03-31

Locations

34 sites across 3 countries: United States, Australia, Taiwan

Regulatory

• FDA-regulated device study