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.
≥ 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.
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
Single group
FARAPULSE™ Pulsed Field Ablation System
DeviceThe 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).
Primary safety endpoint rate
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.
The proportion of Treatment Subjects with confirmed electrical block across all anatomical locations ablated with the investigational system only (Acute Procedural Success).
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