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