RecruitingPersistent Atrial Fibrillation

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

Eligible age

18+ yrs

Accepts

All genders

Locations

21 states

Healthy volunteers

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About this study

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.

Sponsor: Boston Scientific Corporation

You may qualify if…

✓ ≥ 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.
✓ OR
✓ If diagnosed with PersAF prior to the Index Procedure, documented recurrence of symptomatic AF or atypical AFL at least 60 days after the Index Procedure, captured by any regulatory cleared rhythm monitoring device.
✓ Willing and capable of providing informed consent
✓ Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center

You may not qualify if…

✕ 1. Atrial exclusions - Any of the following atrial conditions:
✕ a. Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non-indexed volume \>100 ml (physician note or imaging) b. Current atrial myxoma c. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible) d. Current left atrial thrombus
✕ 2. Cardiovascular exclusions - Any of the following CV conditions:
✕ 1. History of sustained ventricular tachycardia or any ventricular fibrillation
✕ 2. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
✕ 3. 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.
✕ Prior interatrial baffle, atrial septal patch, atrial septal defect closure device, patent foramen ovale occluder Left atrial appendage closure devices are excluded, with the exception of WATCHMAN. WATCHMAN is excluded if implanted within 90 days of enrollment
✕ 4. Presence of any of the following: