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

NCT06735534 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Persistent Atrial Fibrillation

Interventions

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).

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Moussa Mansour,, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-03
Primary Completion
2027-04-30
Completion
2028-01-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06735534 on ClinicalTrials.gov