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

NCT06735534 | Active Not Recruiting DMC FDA Device

• 1 other identifier: PF313
• Study Type: interventional
• Target: 376
• Locations: 3 countries
• Sites: 41

Brief Summary

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.

Conditions

Persistent Atrial Fibrillation

Keywords

Pulsed Field Ablation (PFA)); Pulmonary Vein Isolation; Recurrent Arrhythmia; cavo-tricuspid isthmus (CTI); CTI dependent flutter; Anti Arrhythmic Drugs (AAD); Atrial Flutter; Atrial Tachycardia; Atrial fibrillation; Electrical cardioversion

Outcome Measures

Primary Outcomes (2)

• 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.

  60 days

• 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).

  24 hours

Study Arms (1)

Single Arm Prospective

OTHER

Repeat Ablation of Persistent Atrial Fibrillation, including Mitral Isthmus Catheter Ablation, with the FARAPULSE Pulsed Field Ablation System.

Device: FARAPULSE™ Pulsed Field Ablation System

Interventions

FARAPULSE™ Pulsed Field Ablation System DEVICE

The 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).

Single Arm Prospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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:

• 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
• 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:

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (41)

Mobile Infirmary Medical Center

Mobile, Alabama, 36607, United States

Location

Arrhythmia Research Group-Research Facility

Jonesboro, Arkansas, 72401, United States

Location

University of Southern California Hospital

Los Angeles, California, 90033, United States

Location

St. John's Regional Medical Center

Oxnard, California, 93030, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

South Denver Cardiology Associates, PC

Littleton, Colorado, 80120, United States

Location

HCA Florida Mercy Hospital

Miami, Florida, 33133, United States

Location

Naples Comprehensive Health

Naples, Florida, 34102, United States

Location

AdventHealth Orlando-Hospital

Orlando, Florida, 32803, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

AdventHealth Tampa-Hospital

Tampa, Florida, 33613, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Atrium Health Navicent The Medical Center

Macon, Georgia, 32201, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

St. Luke's Boise Medical Center

Boise, Idaho, 83712, United States

Location

Advocate Christ Medical Center-Hospital

Oak Lawn, Illinois, 60453, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Southcoast Physicians Group

Fall River, Massachusetts, 02720, United States

Location

William Beaumont Hospital-Hospital

Royal Oak, Michigan, 48073, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Virtua Health Inc.

Marlton, New Jersey, 08053, United States

Location

Lovelace Medical Center

Albuquerque, New Mexico, 87102, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

Weill Cornell Medical University

New York, New York, 10065, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

Trident Medical Center

Charleston, South Carolina, 29406, United States

Location

Texas Cardiac Arrhythmia Research

Austin, Texas, 78705, United States

Location

Christus Trinity Mother Frances Health System

Tyler, Texas, 75701, United States

Location

St. Mark's Hospital

Salt Lake City, Utah, 84124, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

John Hunter Hospital

New Lambton Heights, New South Wales, 606-8507, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

St. Andrew's War Memorial Hospital

Brisbane, Queensland, 4001, Australia

Location

Victorian Heart Hospital

Clayton, Victoria, 3168, Australia

Location

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

The Alfred Hospital

Melbourne, Australia

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Atrial Flutter

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Moussa Mansour,, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: June 3, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6); TW (2); US (33)