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NCT06735534NARecruiting

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

Boston Scientific Corporation

Start Date

6/3/2025

Completion Date

1/1/2028

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * ≥ 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 Exclusion Criteria: 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: • Any prosthetic heart valve, ring or repair • Moderate to severe mitral valve stenosis • More than moderate mitral regurgitation (\>3+) * Moderate to severe aortic stenosis 5. Hypertrophic cardiomyopathy 6. Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access 7. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months 8. Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data. 3. Any of the following conditions at baseline: 1. Heart failure associated with NYHA Class III or IV 2. Documented LVEF \< 40% as documented within the previous 12 months 3. 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 4. Body Mass Index (BMI) \>45.0 5. CHA2DS2-VASc score ≥5 4. Any of the following events within 90 Days of the Consent Date: 1. 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 2. Cardiac surgery: Any cardiac surgery 3. Heart failure hospitalization: Heart failure hospitalization 4. Pericardium: Pericarditis or symptomatic pericardial effusion 5. GI bleeding: Gastrointestinal bleeding 6. Neurovascular event: Stroke, TIA, or intracranial bleeding 7. Thromboembolism: Any active non-neurologic thrombus and/or thromboembolic event 8. Carotid intervention: Carotid stenting or endarterectomy 9. Diabetes: Uncontrolled diabetes mellitus or a recorded HgbA1c \> 8.0% 5. Any of the following congenital conditions: 1. Congenital heart disease: Congenital heart disease with any clinically significant residual anatomic or conduction abnormality 2. Methemoglobinemia: History of known congenital methemoglobinemia 3. G6PD deficiency: History of known G6PD deficiency 6. Any of the following conditions: 1. Transplantation: Solid organ or hematologic transplant, or currently being evaluated for a transplant 2. 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. l. 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. n. 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. p. Life expectancy: Predicted life expectancy less than one (1) year

Interventions

DEVICE

FARAPULSE™ Pulsed Field Ablation System

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Conditions

Persistent Atrial Fibrillation

Locations

Mobile Infirmary Medical Center

Mobile, Alabama 36607

United States

Arrhythmia Research Group-Research Facility

Jonesboro, Arkansas 72401

United States

University of Southern California Hospital

Los Angeles, California 90033

United States

St. John's Regional Medical Center

Oxnard, California 93030

United States

Stanford University Medical Center

Stanford, California 94305

United States

South Denver Cardiology Associates, PC

Littleton, Colorado 80120

United States

HCA Florida Mercy Hospital

Miami, Florida 33133

United States

Naples Comprehensive Health

Naples, Florida 34102

United States

AdventHealth Orlando-Hospital

Orlando, Florida 32803

United States

Tampa General Hospital

Tampa, Florida 33606

United States

AdventHealth Tampa-Hospital

Tampa, Florida 33613

United States

Emory University Hospital

Atlanta, Georgia 30322

United States

Atrium Health Navicent The Medical Center

Macon, Georgia 32201

United States

Memorial Health University Medical Center

Savannah, Georgia 31404

United States

St. Luke's Boise Medical Center

Boise, Idaho 83712

United States

Advocate Christ Medical Center-Hospital

Oak Lawn, Illinois 60453

United States

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Southcoast Physicians Group

Fall River, Massachusetts 02720

United States

William Beaumont Hospital-Hospital

Royal Oak, Michigan 48073

United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

Virtua Health Inc.

Marlton, New Jersey 08053

United States

Lovelace Medical Center

Albuquerque, New Mexico 87102

United States

Northwell Health

Manhasset, New York 11030

United States

Weill Cornell Medical University

New York, New York 10065

United States

Bethesda North Hospital

Cincinnati, Ohio 45242

United States

Ohio State University Medical Center

Columbus, Ohio 43210

United States

Oklahoma Heart Institute

Tulsa, Oklahoma 74104

United States

Trident Medical Center

Charleston, South Carolina 29406

United States

Texas Cardiac Arrhythmia Research

Austin, Texas 78705

United States

Christus Trinity Mother Frances Health System

Tyler, Texas 75701

United States

St. Mark's Hospital

Salt Lake City, Utah 84124

United States

Sentara Norfolk General Hospital

Norfolk, Virginia 23507

United States

John Hunter Hospital

New Lambton Heights, New South Wales 606-8507

Australia

Westmead Hospital

Westmead, New South Wales 2145

Australia

St. Andrew's War Memorial Hospital

Brisbane, Queensland 4001

Australia

Victorian Heart Hospital

Clayton, Victoria 3168

Australia

The Royal Melbourne Hospital

Parkville, Victoria 3050

Australia

The Alfred Hospital

Melbourne,

Australia

National Taiwan University Hospital

Taipei,

Taiwan

Taipei Veterans General Hospital

Taipei,

Taiwan