Back to search results

Pulsed Field Ablation for Persistent Atrial Fibrillation

This study is comparing two ways to treat persistent atrial fibrillation (AF), a type of irregular heartbeat, using a procedure called pulsed field ablation (PFA). One approach uses the FARAPULSE Pulsed Field Ablation System along with the OptiMap System to target specific areas in the heart. The other approach uses the FARAPULSE Pulsed Field Ablation System to treat the pulmonary veins and the back wall of the left atrium. The study aims to see if the first approach is as safe and effective as the second for people with symptomatic, drug-resistant persistent AF. To join, you must be at least 18 years old and have persistent AF for more than 7 days but less than 365 days, confirmed by medical records and a 24-hour ECG. The study plans to enroll 699 participants.

Study design
This is an interventional study comparing two different pulsed field ablation methods. It plans to enroll 699 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be checked for 60 days, and the treatment's effectiveness will be monitored for 365 days.

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

NCT07187115

A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation

Active, Not Recruiting
NAAges 18+InterventionalTreatment
Boston Scientific Corporation
~699 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:FARAPOINT Pulsed Field Ablation SystemOptiMap System (non-ablative)FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System

At a glance

Recruiting sites
0 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Endpoint
Measured over 60 Days
+1 more outcome measured

Conditions

Atrial Fibrillation (AF)
Persistant Atrial Fibrillation

Explore related trials

Atrial Fibrillation

NCT07187115

Where you'd take part

This study runs at 15 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arrhythmia Research Group

    Jonesboro, Arkansasno site contact published

  • AZORG

    Aalst, Belgiumno site contact published

  • Christus Trinity Mother Frances Health System

    Tyler, Texasno site contact published

  • Cleveland Clinic Foundation

    Cleveland, Ohiono site contact published

  • Clinica Universidad de Navarra

    Pamplona, Navarre, Spainno site contact published

  • Emory University Hospital

    Atlanta, Georgiano site contact published

  • Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse

    Hasselt, Belgiumno site contact published

  • Mount Sinai Medical Center

    New York, New Yorkno site contact published

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

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Documentation, such as physician note, of persistent continuous AF for \> 7 days and ≤ 365 days and the arrhythmia symptoms
Documentation, within 180 days of enrollment date of either:
A 24-hour continuous ECG recording confirming continuous AF or
Two (2) ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days apart 3. Willing and capable of providing informed consent 4. Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center 5. Willing to receive LUX-Dx™ insertable cardiac monitor (ICM) during the study or already has a LUX-Dx™ ICM that was inserted ≤ 6 months (i.e., within 180 days) of consent, and willing to comply to the LUX-Dx Latitude Clarity transmission instructions

Exclusion

Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices
Implantable loop recorder, other than LUX-Dx
Interatrial baffle, patent foramen ovale or atrial septal defect closure device or patch
Any left atrial appendage closure or occlusion device 5. Presence of any of the following valvular conditions:
Any prosthetic heart valve, stenotic valves, ring or repair
Moderate to severe mitral valve stenosis
More than moderate mitral regurgitation 6. Hypertrophic or amyloid cardiomyopathy 7. Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access 8. Awaiting cardiac transplantation or other planned cardiac surgery within the next 12 months 9. Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data. 3. Any of the following conditions at Baseline:

What this trial measures

  • Primary Safety Endpoint60 Days

    The primary safety endpoint is the rate of ITT subjects in the PVI+EGF arm with one or more of the following serious device- or procedure-related Composite Adverse Events (CAEs) assessed through 60 days following the Index Procedure.

  • Primary Effectiveness Endpoint365 Days

    The primary effectiveness endpoint is the rate of ITT subjects with treatment success in the PVI+EGF arm vs. the PVI+PWA control arm through Day 365, aiming to demonstrate non-inferiority of PVI+EGF compared to the PVI+PWA control.