Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06735534

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

Led by Boston Scientific Corporation · Updated on 2026-05-05

376

Participants Needed

39

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older, or older if required by local law
  • Single previous endocardial atrial fibrillation ablation procedure for paroxysmal or persistent atrial fibrillation including pulmonary vein isolation
  • Documented diagnosis of persistent atrial fibrillation before or after the initial procedure
  • Documented evidence of symptomatic atrial fibrillation recurrence at least 60 days after the initial procedure captured by an approved rhythm monitoring device
  • Willing and able to provide informed consent
  • Willing and able to participate in all follow-up assessments and testing at an approved clinical center
Not Eligible

You will not qualify if you...

  • Left atrial diameter ≥ 5.5 cm or left atrial volume > 100 ml if diameter not available
  • Current atrial myxoma
  • Pulmonary vein abnormalities, stenosis, or stenting (except common and middle pulmonary veins)
  • Current left atrial thrombus
  • History of sustained ventricular tachycardia or ventricular fibrillation
  • Atrial fibrillation due to reversible causes such as electrolyte imbalance, thyroid disease, or alcohol
  • Current or planned implantable cardioverter defibrillator, cardiac resynchronization therapy device, or implantable loop recorder (except LUX-Dx); pacemaker-dependent patients excluded
  • Prior interatrial baffle, atrial septal patch, defect closure device, or recent left atrial appendage closure device (WATCHMAN excluded if implanted within 90 days)
  • Presence of prosthetic heart valve, moderate to severe mitral valve stenosis or regurgitation, moderate to severe aortic stenosis
  • Hypertrophic cardiomyopathy
  • Inferior vena cava filter or inability to obtain vascular access
  • Awaiting cardiac transplantation or surgery within 12 months
  • Severe right ventricular dysfunction
  • NYHA Class III or IV heart failure
  • Left ventricular ejection fraction below 40% within past 12 months
  • Uncontrolled hypertension (SBP >160 mmHg or DBP >95 mmHg)
  • Body mass index over 45
  • CHA2DS2-VASc score 5 or higher
  • Recent (within 90 days) myocardial infarction, unstable angina, coronary intervention, cardiac surgery, heart failure hospitalization, pericarditis, gastrointestinal bleeding, stroke, thromboembolism, carotid intervention
  • Uncontrolled diabetes (HbA1c >8.0%)
  • Significant congenital heart disease, methemoglobinemia, or G6PD deficiency
  • Solid organ or hematologic transplant or evaluation for transplant
  • Diaphragmatic paralysis or paresis
  • Severe lung disease, pulmonary hypertension, or oxygen requirement
  • Renal insufficiency (eGFR <30) or dialysis history
  • Active malignancy (except squamous cell carcinoma)
  • Significant gastrointestinal problems
  • Active systemic infection
  • Use of phosphodiesterase inhibitors within 24 hours before ablation
  • Allergy to nitroglycerin
  • Coagulopathy or bleeding disorders
  • Contraindication or unwillingness to use anticoagulation
  • Pregnancy or planning pregnancy without medical birth control
  • Health conditions preventing study participation or affecting results
  • Unwillingness or inability to tolerate LUX-Dx ICM device
  • Current participation in conflicting investigational studies
  • Life expectancy less than one year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 39 locations

1

Mobile Infirmary Medical Center

Mobile, Alabama, United States, 36607

Actively Recruiting

2

Arrhythmia Research Group-Research Facility

Jonesboro, Arkansas, United States, 72401

Actively Recruiting

3

University of Southern California Hospital

Los Angeles, California, United States, 90033

Actively Recruiting

4

St. John's Regional Medical Center

Oxnard, California, United States, 93030

Actively Recruiting

5

Stanford University Medical Center

Stanford, California, United States, 94305

Actively Recruiting

6

South Denver Cardiology Associates, PC

Littleton, Colorado, United States, 80120

Actively Recruiting

7

HCA Florida Mercy Hospital

Miami, Florida, United States, 33133

Actively Recruiting

8

Naples Comprehensive Health

Naples, Florida, United States, 34102

Actively Recruiting

9

AdventHealth Orlando-Hospital

Orlando, Florida, United States, 32803

Not Yet Recruiting

10

Tampa General Hospital

Tampa, Florida, United States, 33606

Not Yet Recruiting

11

Emory University Hospital

Atlanta, Georgia, United States, 30322

Actively Recruiting

12

Memorial Health University Medical Center

Savannah, Georgia, United States, 31404

Actively Recruiting

13

St. Luke's Boise Medical Center

Boise, Idaho, United States, 83712

Actively Recruiting

14

Advocate Christ Medical Center-Hospital

Oak Lawn, Illinois, United States, 60453

Not Yet Recruiting

15

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Actively Recruiting

16

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

17

Southcoast Physicians Group

Fall River, Massachusetts, United States, 02720

Actively Recruiting

18

William Beaumont Hospital-Hospital

Royal Oak, Michigan, United States, 48073

Actively Recruiting

19

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

20

Virtua Health Inc.

Marlton, New Jersey, United States, 08053

Actively Recruiting

21

Lovelace Medical Center

Albuquerque, New Mexico, United States, 87102

Actively Recruiting

22

Northwell Health

Manhasset, New York, United States, 11030

Actively Recruiting

23

Weill Cornell Medical University

New York, New York, United States, 10065

Actively Recruiting

24

Bethesda North Hospital

Cincinnati, Ohio, United States, 45242

Actively Recruiting

25

Ohio State University Medical Center

Columbus, Ohio, United States, 43210

Actively Recruiting

26

Oklahoma Heart Institute

Tulsa, Oklahoma, United States, 74104

Actively Recruiting

27

Trident Medical Center

Charleston, South Carolina, United States, 29406

Actively Recruiting

28

Texas Cardiac Arrhythmia Research

Austin, Texas, United States, 78705

Actively Recruiting

29

Christus Trinity Mother Frances Health System

Tyler, Texas, United States, 75701

Actively Recruiting

30

St. Mark's Hospital

Salt Lake City, Utah, United States, 84124

Actively Recruiting

31

Sentara Norfolk General Hospital

Norfolk, Virginia, United States, 23507

Actively Recruiting

32

John Hunter Hospital

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

Actively Recruiting

33

Westmead Hospital

Westmead, New South Wales, Australia, 2145

Actively Recruiting

34

St. Andrew's War Memorial Hospital

Brisbane, Queensland, Australia, 4001

Actively Recruiting

35

Victorian Heart Hospital

Clayton, Victoria, Australia, 3168

Actively Recruiting

36

The Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

Actively Recruiting

37

The Alfred Hospital

Melbourne, Australia

Actively Recruiting

38

National Taiwan University Hospital

Taipei, Taiwan

Actively Recruiting

39

Taipei Veterans General Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

K

Kristin Mathson

CONTACT

K

Kaitlyn Aldrich

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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