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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Scientific Corporation

About this trial

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.

Eligibility criteria

Qualifiers

≥ 18 years of age, or older if required by local law

Single previous endocardial AF ablation procedure for PAF or PersAF that minimally included pulmonary vein isolation

Documented (physician's note) diagnosis of PersAF either prior to the subject's Index Procedure OR development of PersAF after the Index Procedure.

Documented evidence of symptomatic AF recurrence at least 60 days after the subject's Index Procedure, captured by any regulatory cleared rhythm monitoring device.

Disqualifiers

History of sustained ventricular tachycardia or any ventricular fibrillation

AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes

Current or anticipated implantable cardioverter defibrillator, cardiac resynchronization therapy devices, or implantable loop recorders, other than LUX-Dx. Patients with a pacemaker are permitted; however, pacemaker-dependent patients are excluded.

Moderate to severe aortic stenosis

Trial design

Treatments tested in this trial

  • FARAPULSE™ Pulsed Field Ablation System

Treatment groups

376 Participants
are divided into 1 treatment group

Sponsors and collaborators