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

Running, not enrolling · Not applicable

Conditions studied: Atrial Fibrillation (AF), Persistant Atrial Fibrillation

In brief

The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources) and to demonstrate its non-inferiority in effectiveness compared to PFA of Pulmonary Veins and LA Posterior Wall (PVI+ PWA) in the treatment of de novo symptomatic drug-refractory persistent atrial fibrillation (PersAF).

Key facts

Study ID

NCT07187115

Run by

Boston Scientific Corporation

People needed

699

Starts

2025-11-07

Expected to finish

2030-12-01

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age, or older if required by local law
• Have symptomatic drug-refractory1, persistent AF2, confirmed by both:
• 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
• 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
• 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

You may not qualify if…

• Any of the following atrial conditions:
• Left atrial anteroposterior diameter ≥ 5.5 cm, or if1 LA diameter not available, non-indexed volume >100 ml (physician note or imaging)
• Any prior left atrial ablation
• Any prior atrial surgery
• Current atrial myxoma
• Current left atrial thrombus
• Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
• Any of the following cardiovascular conditions:
• History of sustained ventricular tachycardia or any ventricular fibrillation
• Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data, per Investigator's discretion
• AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
• Cardiac devices and implants:
• 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
• 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
• Hypertrophic or amyloid cardiomyopathy
• Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access
• Awaiting cardiac transplantation or other planned cardiac surgery within the next 12 months
• Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data.
• Any of the following conditions at Baseline:

Where it is running

• Arrhythmia Research Group — Jonesboro, Arkansas, United States
• Pacific Heart Institute — Santa Monica, California, United States
• Piedmont Athens Regional — Athens, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• St. Luke's Boise Medical Center — Boise, Idaho, United States
• Mount Sinai Medical Center — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States
• Christus Trinity Mother Frances Health System — Tyler, Texas, United States
• AZORG — Aalst, Belgium
• Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse — Hasselt, Belgium
• Prince of Wales Hosptial — Shatin, Hong Kong, Hong Kong
• Clinica Universidad de Navarra — Pamplona, Navarre, Spain

Full record on ClinicalTrials.gov

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