Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation

Running, not enrolling · Not applicable

Conditions studied: Persistent Atrial Fibrillation

In brief

The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs.

Key facts

Study ID

NCT06096337

Run by

Boston Scientific Corporation

People needed

484

Starts

2023-12-28

Expected to finish

2028-02-04

Last updated by the study team

2026-07-27

Who can join

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

You may qualify if…

• Age ≥ 18 years of age, or older if specified by local law
• Have symptomatic persistent AF, confirmed by both:
• a. Documentation, within 180 days of randomization, or treatment assignment for roll-in subjects, of either: i. A 24-hour continuous ECG recording (from any regulatory cleared rhythm monitoring device) confirming continuous AF, OR ii. Two ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days apart b. Documentation, such as physician note, of persistent continuous AF for > 7 days and ≤ 365 days
• Willing and capable of providing informed consent
• Willing and capable of participating in all 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

You may not qualify if…

• Treated with AAD (Class I or III) ≤ 6 months (i.e., within 180 days) before enrollment,
• More than 7-day history of therapeutic AAD use (Class I or III), or
• ≥ 24 hours amiodarone, i Note Pill-in-the-pocket AAD use, is permitted.
• Treated with AAD ( Class I or III) > 6 months (i.e., more than 180 days) before enrollment and experienced AAD failure (adverse drug effects or frequent AF episodes)
• Contraindication to, or unwillingness to use, AADs (Class I and III, excluding amiodarone)
• Contraindication to PFA treatment
• Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra-, and post-procedure to achieve adequate anticoagulation.
• Any of the following atrial conditions:
• Left atrial (LA) anteroposterior diameter ≥ 5.5 cm, or, if LA diameter not available, non-indexed volume >100 ml, as documented by physician note or imaging (Note: if both values are available, only the LA diameter will be used to confirm eligibility criteria)
• Any prior atrial endocardial, epicardial or surgical ablation procedure for arrhythmia, other than right sided cavotricuspid isthmus ablation or for right sided supraventricular tachycardia
• Current atrial myxoma
• Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
• Current left atrial thrombus
• Any of the following cardiovascular conditions:
• History of sustained ventricular tachycardia or any ventricular fibrillation
• AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
• Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, interatrial baffle, atrial septal patch, atrial septal defect closure device, or patent foramen ovale occluder
• Valvular disease that is any of the following: i. Symptomatic, ii. Causing or exacerbating congestive heart failure, iii. Associated with abnormal left ventricular (LV) function or hemodynamic measurements
• Hypertrophic cardiomyopathy
• Cardiac amyloidosis
• Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
• Any inferior vena cava (IVC) filter, known inability to obtain vascular access or other contraindication to femoral access
• Rheumatic heart disease
• Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
• Awaiting cardiac transplantation or other cardiac surgery within the next 12 months

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Banner University Medical Center Phoenix — Phoenix, Arizona, United States
• Phoenix Cardiovascular Research Group — Phoenix, Arizona, United States
• Arrhythmia Research Group — Jonesboro, Arkansas, United States
• Scripps Memorial Hosptial — La Jolla, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Cardiology Associates Medical Group, Inc — Ventura, California, United States
• HCA Florida Mercy Hospital — Miami, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Tallahassee Memorial Hospital — Tallahassee, Florida, United States
• St. Joseph's Hospital — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Memorial Health University Medical Center — Savannah, Georgia, United States
• St. John's Hospital — Springfield, Illinois, United States
• Community Heart and Vascular Hospital — Indianapolis, Indiana, United States
• Mercy Hospital Medical Center-Hospital — West Des Moines, Iowa, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Southcoast Physicians Group — Fall River, Massachusetts, United States
• University of Michigan Hospitals — Ann Arbor, Michigan, United States
• Corewell Health — Grand Rapids, Michigan, United States
• Mayo Clinic Foundation-Hospital — Rochester, Minnesota, United States
• Catholic Medical Center — Manchester, New Hampshire, United States
• Prince of Wales Hospital — Shatin, Hong Kong

Full record on ClinicalTrials.gov

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