Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation

Stopped early · Not applicable

Conditions studied: Atrial Fibrillation Paroxysmal

In brief

The purpose of this study is to compare the efficacy and safety between pulmonary vein isolation (PVI) alone versus PVI with left atrial (LA) posterior wall isolation (PWI) using pulsed-field ablation (PFA) in the treatment of patients with paroxysmal atrial fibrillation (PAF).

Key facts

Study ID

NCT06364215

Run by

Jorge Romero

People needed

198

Starts

2024-10-08

Expected to finish

2025-11-16

Last updated by the study team

2026-05-15

Who can join

Age: 21 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Age 21-90 years.
• Symptomatic PAF whether failed AAD or not.
• At least one symptomatic episode of PAF lasting <7 days, documented on electrocardiogram (ECG), Holter, ZioPatch, ILR, or smartwatch recording in the year prior to enrollment.
• Patients undergoing first time ablation for AF.
• Subject has any commercially available implantable loop recorder (ILR) or agrees to have one implanted prior or during the ablation procedure.

You may not qualify if…

• Persistent atrial fibrillation (PeAF) (> 7 days in duration).
• Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or other reversible non-cardiac cause.
• Previous surgical or catheter ablation of AF.
• Previous valve surgery, ventriculotomy, atriotomy, or presence of a mitral mechanical prosthetic or bioprosthetic valve.
• Left atrium anteroposterior (LA AP) diameter >55 mm or indexed left atrium (LA) volume >48 ml/m2.
• Contraindications to oral or systemic anticoagulation.
• Previous thromboembolic event (including ischemic strokes and TIA) within the last 3 months.
• Previous myocardial infarction or percutaneous coronary intervention within the past 2 months.
• Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days).
• Pregnancy.
• History of PV stenosis.
• History of severe pulmonary hypertension.
• History of diaphragmatic paresis or hemi-paresis.
• History of heart transplantation.
• History of blood clotting or bleeding abnormalities.
• Life expectancy of less than 12 months.
• Presence of intracardiac thrombus.
• Complex congenital heart disease, including tetralogy of Fallot, ventricular septal defects, Ebstein's anomaly, systemic right ventricle, and transposition of the great arteries.
• Intracardiac or vascular abnormalities that preclude adequate catheter introduction or manipulation within the LA.
• Pacing dependent patients.
• Active malignancy or history of treated malignancy within 12 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma).
• Active systemic infection.
• Participation in any other AF-related randomized clinical trial.

Where it is running

• Grandview Medical Center — Birmingham, Alabama, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• St. Vincent's Health System, Inc. d/b/a Ascension St. Vincent's — Jacksonville, Florida, United States
• HCA Florida Mercy Hospital — Miami, Florida, United States
• St. Luke's Boise Medical Center — Boise, Idaho, United States
• Maine Medical Center — Portland, Maine, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Lahey Hospital and Medical Center — Burlington, Massachusetts, United States
• Corewell Health William Beaumont Hospital — Royal Oak, Michigan, United States
• The Valley Hospital — Paramus, New Jersey, United States
• North Shore University Hospital, Northwell Health — Manhasset, New York, United States
• Doylestown Hospital — Doylestown, Pennsylvania, United States
• Trident Medical Center — Charleston, South Carolina, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Orion Medical — Houston, Texas, United States
• Methodist Hospital-San Antonio — San Antonio, Texas, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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