Persistent Atrial FibrillationReMATCHNCT06735534
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
A study testing FARAPULSE™ Pulsed Field Ablation System in people with Persistent Atrial Fibrillation, run by Boston Scientific Corporation at 41 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- FARAPULSE™ Pulsed Field Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 41 sitesin 3 countries
- Study dates
- 3 Jun 2025to Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- Atrial exclusions - Any of the following atrial conditions:
- 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.
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- 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
- Heart failure hospitalization: Heart failure hospitalization
- Pericardium: Pericarditis or symptomatic pericardial effusion
- GI bleeding: Gastrointestinal bleeding
- Neurovascular event: Stroke, TIA, or intracranial bleeding
- Thromboembolism: Any active non-neurologic thrombus and/or thromboembolic event
- Carotid intervention: Carotid stenting or endarterectomy
- Diabetes: Uncontrolled diabetes mellitus or a recorded HgbA1c > 8.0%
- Any of the following congenital conditions:
- Congenital heart disease: Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
- Methemoglobinemia: History of known congenital methemoglobinemia
- G6PD deficiency: History of known G6PD deficiency
- Any of the following conditions:
- Transplantation: Solid organ or hematologic transplant, or currently being evaluated for a transplant
- Diaphragmatic abnormality: Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis.
- Pulmonary: Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen d. Renal: Renal insufficiency if an estimated glomerular filtration rate (eGFR) is < 30 mL / min / 1.73 m2, or with any history of renal dialysis or renal transplant e. Malignancy: Active malignancy (other than squamous cell carcinoma) f. Gastrointestinal: Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration g. Infections: Active systemic infection h. Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure i. Nitroglycerin intolerance: Known allergic drug reaction to nitroglycerin (excluding hypotension) j. Hematologic condition: Known coagulopathy or bleeding disorder (e.g. von Willebrand disease, hemophilia) k. Contraindication to anticoagulation: Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation.
- Pregnancy: Women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period m. General health conditions: Health conditions that, in the investigator's medical opinion, would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation.
- LUX-Dx ICM intolerance: Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx ICM device o. Participation in another trial: Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility.
- Life expectancy: Predicted life expectancy less than one (1) year
Trial locations and contacts
41 sites in 3 countries.
41 sites in 3 countries
United States33 sites
Lovelace Medical Center
Albuquerque, New Mexico, 87102
Emory University Hospital
Atlanta, Georgia, 30322
Texas Cardiac Arrhythmia Research
Austin, Texas, 78705
Johns Hopkins Hospital
Baltimore, Maryland, 21287
St. Luke's Boise Medical Center
Boise, Idaho, 83712
Massachusetts General Hospital
Boston, Massachusetts, 02114
Trident Medical Center
Charleston, South Carolina, 29406
Bethesda North Hospital
Cincinnati, Ohio, 45242
Ohio State University Medical Center
Columbus, Ohio, 43210
Southcoast Physicians Group
Fall River, Massachusetts, 02720
Arrhythmia Research Group-Research Facility
Jonesboro, Arkansas, 72401
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
South Denver Cardiology Associates, PC
Littleton, Colorado, 80120
University of Southern California Hospital
Los Angeles, California, 90033
Atrium Health Navicent The Medical Center
Macon, Georgia, 32201
Northwell Health
Manhasset, New York, 11030
Virtua Health Inc.
Marlton, New Jersey, 08053
HCA Florida Mercy Hospital
Miami, Florida, 33133
Mobile Infirmary Medical Center
Mobile, Alabama, 36607
Naples Comprehensive Health
Naples, Florida, 34102
Weill Cornell Medical University
New York, New York, 10065
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Advocate Christ Medical Center-Hospital
Oak Lawn, Illinois, 60453
AdventHealth Orlando-Hospital
Orlando, Florida, 32803
St. John's Regional Medical Center
Oxnard, California, 93030
William Beaumont Hospital-Hospital
Royal Oak, Michigan, 48073
St. Mark's Hospital
Salt Lake City, Utah, 84124
Memorial Health University Medical Center
Savannah, Georgia, 31404
Stanford University Medical Center
Stanford, California, 94305
Tampa General Hospital
Tampa, Florida, 33606
AdventHealth Tampa-Hospital
Tampa, Florida, 33613
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
Christus Trinity Mother Frances Health System
Tyler, Texas, 75701
Australia6 sites
St. Andrew's War Memorial Hospital
Brisbane, Queensland, 4001
Victorian Heart Hospital
Clayton, Victoria, 3168
The Alfred Hospital
Melbourne
John Hunter Hospital
New Lambton Heights, New South Wales, 606-8507
The Royal Melbourne Hospital
Parkville, Victoria, 3050
Westmead Hospital
Westmead, New South Wales, 2145
Taiwan2 sites
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
About this study
Official title: 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
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.
Read the detailed description
The goal of this study is to evaluate the safety and effectiveness of using the FARAWAVE™ and FARAPOINT™ pulsed field ablation (PFA) catheters for re-treatment of persistent atrial fibrillation (PersAF) after a failed initial procedure.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- FARAPULSE™ Pulsed Field Ablation System
- 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
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FARAPULSE™ Pulsed Field Ablation SystemDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Prospective | Other | Repeat Ablation of Persistent Atrial Fibrillation, including Mitral Isthmus Catheter Ablation, with the FARAPULSE Pulsed Field Ablation System. Receives: Device: FARAPULSE™ Pulsed Field Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start3 Jun 2025
- Primary completionApr 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moussa Mansour,, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735534
- Sponsor's protocol ID
- PF313
- Acronym
- ReMATCH
- Status last verified
- Oct 2026
- First submitted
- 11 Dec 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No