🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT06735534
Recruiting Not applicable

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

NCT06735534 · tracked via the Priya Life Science USA tracker
Sponsor
Boston Scientific Corporation
Phase
Not applicable
Started
2025-06-03
Last updated
2026-08-28

Condition(s) studied

Persistent Atrial Fibrillation

Investigational drug(s) / intervention(s)

FARAPULSE™ Pulsed Field Ablation System

FARAPULSE™ Pulsed Field Ablation System: 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
Mobile Infirmary Medical Center Mobile Alabama Recruiting
Arrhythmia Research Group-Research Facility Jonesboro Arkansas Recruiting
University of Southern California Hospital Los Angeles California Recruiting
St. John's Regional Medical Center Oxnard California Recruiting
Stanford University Medical Center Stanford California Recruiting
South Denver Cardiology Associates, PC Littleton Colorado Recruiting
HCA Florida Mercy Hospital Miami Florida Recruiting
Naples Comprehensive Health Naples Florida Recruiting
AdventHealth Orlando-Hospital Orlando Florida Recruiting
Tampa General Hospital Tampa Florida Recruiting
AdventHealth Tampa-Hospital Tampa Florida Recruiting
Emory University Hospital Atlanta Georgia Recruiting
Atrium Health Navicent The Medical Center Macon Georgia Recruiting
Memorial Health University Medical Center Savannah Georgia Recruiting
St. Luke's Boise Medical Center Boise Idaho Recruiting
Advocate Christ Medical Center-Hospital Oak Lawn Illinois Recruiting
Johns Hopkins Hospital Baltimore Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Southcoast Physicians Group Fall River Massachusetts Recruiting
William Beaumont Hospital-Hospital Royal Oak Michigan Recruiting
Dartmouth Hitchcock Medical Center Lebanon New Hampshire Recruiting
Virtua Health Inc. Marlton New Jersey Recruiting
Lovelace Medical Center Albuquerque New Mexico Recruiting
Northwell Health Manhasset New York Recruiting
Weill Cornell Medical University New York New York Recruiting
Bethesda North Hospital Cincinnati Ohio Recruiting
Ohio State University Medical Center Columbus Ohio Recruiting
Oklahoma Heart Institute Tulsa Oklahoma Recruiting
Trident Medical Center Charleston South Carolina Recruiting
Texas Cardiac Arrhythmia Research Austin Texas Recruiting
Christus Trinity Mother Frances Health System Tyler Texas Recruiting
St. Mark's Hospital Salt Lake City Utah Recruiting
Sentara Norfolk General Hospital Norfolk Virginia Recruiting
John Hunter Hospital New Lambton Heights New South Wales Recruiting
Westmead Hospital Westmead New South Wales Recruiting
St. Andrew's War Memorial Hospital Brisbane Queensland Recruiting
Victorian Heart Hospital Clayton Victoria Recruiting
The Royal Melbourne Hospital Parkville Victoria Recruiting
The Alfred Hospital Melbourne Australia Recruiting
National Taiwan University Hospital Taipei Taiwan Recruiting

+ 1 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06735534 on ClinicalTrials.gov ↗ ← All trials in the USA