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FARAFLEX System for Atrial Fibrillation

This study is testing a new device called the FARAFLEX Mapping and Pulsed Field Ablation (PFA) System to see if it can safely and effectively treat atrial fibrillation (AF). AF is an irregular heartbeat that can be paroxysmal (comes and goes) or persistent (doesn't go away). The study wants to know if the FARAFLEX System is a safe and effective treatment for people with symptomatic AF that hasn't responded to other medicines. You might be able to join if you are at least 18 years old, have symptomatic AF, and are willing to follow the study procedures. Researchers will look at how many people have serious side effects within 60 days of the procedure, and how many are successfully treated after one year.

Study design
This study plans to enroll 571 participants. It is an interventional study, meaning participants will receive the FARAFLEX Mapping and PFA System.
What's involved
Participants will undergo an ablation procedure using the FARAFLEX Mapping and PFA System. You will also need to attend follow-up assessments and study procedures.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for 60 days after the procedure, and for effectiveness for up to 365 days (one year).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07575269

Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation

Recruiting
NAAges 18+InterventionalTreatment
Boston Scientific Corporation
~571 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:FARAFLEX Mapping and Pulsed Field Ablation (PFA) System

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Treatment Subjects and Attempt Subjects with device- or procedure-related defined Composite Serious Adverse Events, assessed through Day 60 following the index procedure.
Measured over After the index procedure, rescheduled index procedure, or first re-ablation performed with the FARAFLEX (Day 0) through Day 60
+1 more outcome measured

Conditions

Paroxysmal Atrial Fibrillation (PAF)
Persistent Atrial Fibrillation

Explore related trials

Paroxysmal Atrial FibrillationPersistent atrial fibrillation

NCT07575269

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arrhythmia Research Group

    Jonesboro, Arkansasstudy coordinator listed

    Recruiting

  • Christus Trinity Mother Frances Health System-Hospital

    Tyler, Texasstudy coordinator listed

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Mater Private Hospital-Hospital

    Dublin, Dublin, Irelandstudy coordinator listed

    Recruiting

  • Mount Sinai Medical Center-Hospital

    New York, New Yorkstudy coordinator listed

    Recruiting

  • OhioHealth Research and Innovation Institute - Riverside Methodist Hospital

    Columbus, Ohiostudy coordinator listed

    Recruiting

  • Pinnacle Health at Harrisburg Hospital - UPMC Pinnacle

    Mechanicsburg, Pennsylvaniastudy coordinator listed

    Recruiting

  • St. Jan-Hospital

    Bruges, Belgiumstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Andrea Natale, MD · PRINCIPAL_INVESTIGATOR · Texas Cardiac Arrhythmia Research Foundation

Who to contact

Madalyn MacKinnon
[email protected]
860-992-2724
Email the study team

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Eligibility criteria

Exclusion

Current or anticipated pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy device
Current implantable loop recorder other than LUX-Dx
Prior interatrial baffle or septal closure device/patch (Patent Foramen Ovale (PFO)or Atrial Septal Defect (ASD))
Left atrial appendage closure or occlusion device 4. Clinically significant valvular disease, including:
Any cardiac valve prosthesis, ring, repair, or clip
Moderate to severe mitral stenosis
Moderate to severe aortic stenosis
Severe mitral regurgitation
Severe tricuspid regurgitation 5. Hypertrophic or amyloid cardiomyopathy 6. Presence of Inferior Vena Cava (IVC) filter, inability to obtain vascular access, or contraindication to femoral access 7. Awaiting cardiac transplantation or other cardiac surgery within 12 months (left atrial appendage closure/occlusion procedures allowed no less than (≥) 60 days after index procedure) 8. Severe right ventricular dysfunction per investigator assessment 3. Any of the following congenital conditions:

What this trial measures

  • Proportion of Treatment Subjects and Attempt Subjects with device- or procedure-related defined Composite Serious Adverse Events, assessed through Day 60 following the index procedure.After the index procedure, rescheduled index procedure, or first re-ablation performed with the FARAFLEX (Day 0) through Day 60

    Occurrence of defined Composite Serious Adverse Events after the procedure through Day 60.

  • The primary effectiveness endpoint (PEE) is the proportion of Treatment Subjects with Treatment Success through the Day 365 Assessment.Day 0 through the Day 365 Assessment

    Acute Procedural Success defined as Pulmonary Vein (PV) Isolation and Chronic Success. Chronic Success is defined as freedom from the following after the Blanking Period (60 days): * Arrhythmia: Occurrence of any Detectable Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT) * Re-ablation: Any re-ablation for Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT) * Cardioversion: Any electrical cardioversion for Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT) * Antiarrhythmic Drug (AAD) Use: dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new AAD.