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

Recruiting now · Not applicable

Conditions studied: Persistent Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT06735534

Run by

Boston Scientific Corporation

People needed

376

Starts

2025-06-03

Expected to finish

2028-01-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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…

• 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
• Cardiovascular exclusions - Any of the following CV conditions:
• 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.
• 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
• Presence of any of the following:
• Any prosthetic heart valve, ring or repair
• Moderate to severe mitral valve stenosis
• More than moderate mitral regurgitation (>3+)
• Moderate to severe aortic stenosis
• Hypertrophic cardiomyopathy
• Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access
• Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
• Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data.
• Any of the following conditions at baseline:
• Heart failure associated with NYHA Class III or IV
• Documented LVEF < 40% as documented within the previous 12 months
• Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two (2) BP measurements at baseline assessment not attributable to white coat syndrome per Investigator opinion
• Body Mass Index (BMI) >45.0
• CHA2DS2-VASc score ≥5
• Any of the following events within 90 Days of the Consent Date:
• Coronary disease: Myocardial infarction (MI), unstable or Prinzmetal angina or coronary intervention within 90 days of consent or any documented history of severe non-revascularize coronary disease
• Cardiac surgery: Any cardiac surgery

Where it is running

• Mobile Infirmary Medical Center — Mobile, Alabama, United States (enrolling)
• Arrhythmia Research Group-Research Facility — Jonesboro, Arkansas, United States (enrolling)
• University of Southern California Hospital — Los Angeles, California, United States (enrolling)
• St. John's Regional Medical Center — Oxnard, California, United States (enrolling)
• Stanford University Medical Center — Stanford, California, United States (enrolling)
• South Denver Cardiology Associates, PC — Littleton, Colorado, United States (enrolling)
• HCA Florida Mercy Hospital — Miami, Florida, United States (enrolling)
• Naples Comprehensive Health — Naples, Florida, United States (enrolling)
• AdventHealth Orlando-Hospital — Orlando, Florida, United States (enrolling)
• Tampa General Hospital — Tampa, Florida, United States (enrolling)
• AdventHealth Tampa-Hospital — Tampa, Florida, United States (enrolling)
• Emory University Hospital — Atlanta, Georgia, United States (enrolling)
• Atrium Health Navicent The Medical Center — Macon, Georgia, United States (enrolling)
• Memorial Health University Medical Center — Savannah, Georgia, United States (enrolling)
• St. Luke's Boise Medical Center — Boise, Idaho, United States (enrolling)
• Advocate Christ Medical Center-Hospital — Oak Lawn, Illinois, United States (enrolling)
• Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Southcoast Physicians Group — Fall River, Massachusetts, United States (enrolling)
• William Beaumont Hospital-Hospital — Royal Oak, Michigan, United States (enrolling)
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• Virtua Health Inc. — Marlton, New Jersey, United States (enrolling)
• Lovelace Medical Center — Albuquerque, New Mexico, United States (enrolling)
• Northwell Health — Manhasset, New York, United States (enrolling)
• Weill Cornell Medical University — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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