Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation ((SMILE-AF))

Mass General Brigham

Status: Enrolling

Conditions: Atrial Fibrillation Paroxysmal

Treatments: Device: Farapulse PFA, Pulmonary Vein Isolation alone; Device: Farapulse PFA, Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06364215

2024P000883

Details and patient eligibility

About

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).

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 2 patient groups

Pulmonary Vein Isolation (PVI) only

Active Comparator group

Description:

Pulsed field ablation of the pulmonary veins only.

Treatment:

Device: Farapulse PFA, Pulmonary Vein Isolation alone

Pulmonary Vein Isolation and Posterior Wall Isolation ( PVI+PWI)

Active Comparator group

Description:

Pulsed field ablation of the pulmonary veins and the posterior wall of the left atrium.

Treatment:

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