What is the FARAPULSE Pulsed Field Ablation System studying for persistent atrial fibrillation?

The FARAPULSE Pulsed Field Ablation System is being studied to evaluate its safety and effectiveness for re-treating persistent atrial fibrillation in patients after a prior unsuccessful ablation. This research aims to improve treatment options using specialized catheters for heart rhythm control.

Who may be eligible for this persistent atrial fibrillation clinical trial?

Adults aged 18 years and older with a prior atrial fibrillation ablation that included pulmonary vein isolation and documented persistent atrial fibrillation may be eligible. Participants must be willing to provide consent and attend follow-up visits. Please review eligibility criteria for more details.

Is there any cost to participate in this persistent atrial fibrillation clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06735534

Study to Evaluate Safety and Effectiveness of FARAPULSE Pulsed Field Ablation Catheters for Repeat Treatment of Persistent Atrial Fibrillation

Led by Boston Scientific Corporation · Updated on 2026-07-27

376

Participants Needed

Research Sites

39 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of the FARAWAVE and FARAPOINT pulsed field ablation PFA catheters to treat persistent atrial fibrillation PersAF in patients who have had a previous unsuccessful ablation procedure. This prospective, single-arm, open-label, multi-center study aims to assess the safety and effectiveness of re-treating PersAF, including mitral isthmus catheter ablation, using the FARAPULSE PFA System. Participants will undergo repeat ablation with the FARAPULSE PFA System, which includes the FARAWAVE and FARAPOINT catheters. The FARAWAVE Catheter isolates pulmonary veins and the posterior wall, while the FARAPOINT Catheter is used for creating additional ablation lines such as the mitral isthmus. This treatment is delivered as a single-arm intervention without a comparison group. Throughout the study, participants will be monitored for safety and effectiveness outcomes. The primary safety endpoint is assessed within 60 days, while procedural success is evaluated within 24 hours after treatment. Participants must provide informed consent and attend all follow-up visits as scheduled at approved clinical centers. The total study duration extends through primary completion in April 2027 and study completion in January 2028.

CONDITIONS

Brief 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

You may qualify if you...

18 years of age or older, or as required by local law
One previous endocardial atrial fibrillation ablation procedure that included pulmonary vein isolation
Documented diagnosis of persistent atrial fibrillation before or after the initial procedure
Documented symptomatic atrial fibrillation recurrence at least 60 days after the initial procedure, confirmed by a rhythm monitoring device
Willing and capable of providing informed consent
Willing and capable of participating in all follow-up assessments at an approved clinical center

You will not qualify if you...

Left atrial anteroposterior diameter 5.5 cm or larger, or left atrial volume over 100 ml
Presence of 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 like electrolyte imbalance or thyroid disease
Current or planned implantable cardioverter defibrillator, cardiac resynchronization therapy devices, or implantable loop recorders (except LUX-Dx); pacemaker-dependent patients excluded
Prior interatrial baffle or atrial septal closure devices; left atrial appendage closure devices except WATCHMAN implanted more than 90 days before enrollment
Presence of prosthetic heart valves, moderate to severe mitral valve stenosis, or more than moderate mitral regurgitation
Moderate to severe aortic stenosis
Hypertrophic cardiomyopathy
Contraindications to femoral access such as IVC filter or inability to obtain vascular access
Awaiting cardiac transplantation or surgery within 12 months
Severe right ventricular dysfunction
Heart failure NYHA Class III or IV
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 serious cardiovascular events or conditions within 90 days including myocardial infarction, cardiac surgery, heart failure hospitalization, pericarditis, gastrointestinal bleeding, neurovascular event, thromboembolism, carotid intervention
Uncontrolled diabetes or HbA1c over 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 or pulmonary hypertension
Renal insufficiency with eGFR below 30 or history of dialysis or transplant
Active malignancy except squamous cell carcinoma
Severe gastrointestinal diseases
Active systemic infection
Use of phosphodiesterase inhibitors within 24 hours of ablation
Allergy to nitroglycerin (excluding hypotension)
Known bleeding disorders or contraindication to anticoagulation
Pregnancy, lactation, or planning pregnancy without medical birth control
Health conditions preventing safe participation as judged by investigator
Inability or unwillingness to receive LUX-Dx implant
Participation in conflicting trials
Predicted life expectancy less than one year

Research Team

Kristin Mathson

Kaitlyn Aldrich

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Study to Evaluate Safety and Effectiveness of FARAPULSE Pulsed Field Ablation Catheters for Repeat Treatment of Persistent Atrial Fibrillation

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria