Using pulsed field ablation to treat paroxysmal atrial fibrillation

Posterior Wall Substrate Modification Using Irreversible Electroporation for the Treatment of Paroxysmal Atrial Fibrillation

This study is testing whether combining a specific heart procedure with an additional treatment can help people with paroxysmal atrial fibrillation feel better and stay free of heart rhythm problems.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 21 Years to 90 Years
• Sex: All
• Sponsor: Brigham and Women's Hospital (other)
• Locations: 7 sites (Birmingham, Alabama and 6 other locations)
• Trial ID: NCT06364215 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness and safety of pulmonary vein isolation (PVI) alone versus PVI combined with left atrial posterior wall isolation (PWI) using pulsed-field ablation (PFA) in patients with paroxysmal atrial fibrillation (PAF). Participants will be randomly assigned to one of the two treatment groups and monitored closely for 3 months after the procedure. Following this blanking period, anti-arrhythmic drug therapy will be stopped, and patients will be monitored for a year using an implantable loop recorder to evaluate the outcomes. The primary goal is to assess the improvement in freedom from all-atrial arrhythmias and the safety of the procedures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21-90 with symptomatic paroxysmal atrial fibrillation who are undergoing their first ablation procedure.

Not a fit: Patients with persistent atrial fibrillation or those who have previously undergone surgical or catheter ablation for atrial fibrillation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved outcomes for patients with paroxysmal atrial fibrillation by enhancing arrhythmia control.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination of techniques is being evaluated for the first time.

Eligibility criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Age 21-90 years.
4. Symptomatic PAF whether failed AAD or not.
5. 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.
6. Patients undergoing first time ablation for AF.
7. Subject has any commercially available implantable loop recorder (ILR) or agrees to have one implanted prior or during the ablation procedure.

Exclusion Criteria:

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

Where this trial is running

Birmingham, Alabama and 6 other locations

• Grandview Medical Center — Birmingham, Alabama, United States (RECRUITING)
• St. Vincent's Health System, Inc. d/b/a Ascension St. Vincent's — Jacksonville, Florida, United States (RECRUITING)
• HCA Florida Mercy Hospital — Miami, Florida, United States (RECRUITING)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
• North Shore University Hospital, Northwell Health — Manhasset, New York, United States (RECRUITING)
• Doylestown Hospital — Doylestown, Pennsylvania, United States (RECRUITING)
• Trident Medical Center — Charleston, South Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Jorge E Romero, MD — Mass General Brigham
• Study coordinator: Obadah Aloum, MD

Conditions: Atrial Fibrillation Paroxysmal, pulsed field ablation, paroxysmal atrial fibrillation, left atrium posterior wall isolation, pulmonary vein isolation