Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation

Last updated: January 21, 2025
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Dysrhythmia

Arrhythmia

Treatment

Farapulse PFA, Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation

Farapulse PFA, Pulmonary Vein Isolation alone

Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation

Clinical Study ID

NCT06364215
2024P000883
  • Ages 21-90
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision of signed and dated informed consent form.

  2. Stated willingness to comply with all study procedures and availability for theduration 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 onelectrocardiogram (ECG), Holter, ZioPatch, ILR, or smartwatch recording in the yearprior to enrollment.

  6. Patients undergoing first time ablation for AF.

  7. Subject has any commercially available implantable loop recorder (ILR) or agrees tohave one implanted prior or during the ablation procedure.

Exclusion

Exclusion Criteria:

  1. Persistent atrial fibrillation (PeAF) (> 7 days in duration).

  2. Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or otherreversible non-cardiac cause.

  3. Previous surgical or catheter ablation of AF.

  4. Previous valve surgery, ventriculotomy, atriotomy, or presence of a mitralmechanical 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 3months.

  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 septaldefects, Ebstein's anomaly, systemic right ventricle, and transposition of the greatarteries.

  19. Intracardiac or vascular abnormalities that preclude adequate catheter introductionor 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.

Study Design

Total Participants: 450
Treatment Group(s): 4
Primary Treatment: Farapulse PFA, Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation
Phase:
Study Start date:
October 08, 2024
Estimated Completion Date:
October 31, 2028

Study Description

This is an investigator-initiated, prospective, randomized, multi-center, Investigational Device Exemption (IDE) study. Subjects undergoing first-time ablation for paroxysmal atrial fibrillation will be randomized to receive either pulmonary vein isolation (PVI) alone or PVI combined with posterior wall isolation (PWI) using pulsed field ablation (PFA) with the FARAWAVE PFA catheter.

Following the index procedure, all participants will enter a 3-month blanking period, during which they will be closely monitored. After this period, anti-arrhythmic drug (AAD) therapy will be discontinued for all patients. Throughout the entire study, patients will be monitored using an implantable loop recorder (ILR) to assess the primary outcome of efficacy.

The study includes a 12-month follow-up period, and the primary objective is to assess and compare the efficacy, defined as an improvement in freedom from all-atrial arrhythmias, and safety, defined as the occurrence of all procedure-related complications.

Connect with a study center

  • Grandview Medical Center

    Birmingham, Alabama 35243
    United States

    Active - Recruiting

  • St. Vincent's Health System, Inc. d/b/a Ascension St. Vincent's

    Jacksonville, Florida 32204
    United States

    Active - Recruiting

  • HCA Florida Mercy Hospital

    Miami, Florida 33133
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • North Shore University Hospital, Northwell Health

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • Doylestown Hospital

    Doylestown, Pennsylvania 18901
    United States

    Active - Recruiting

  • Trident Medical Center

    Charleston, South Carolina 29406
    United States

    Active - Recruiting

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