LS-PersAFone: Pulsed Field Ablation for Long-Standing Persistent Atrial Fibrillation

This is a prospective, single-arm trial. The objective of the study is to determine the rate of atrial arrhythmia recurrence after pulmonary vein isolation (PVI) plus posterior wall isolation (PWI) using the Farawave PFA catheter in patients with longstanding persistent atrial fibrillation (AF). The trial will be conducted at as many as 10 US sites. Upon completion of site initiation, enrollment is expected to accrue at a rate of 10 patients per month. Total enrollment is expected to consist of 100 subjects. Accrual is expected to take 18 months, and all patients will be followed for 12 months post randomization. This study will be completed in 2 phases. There will be a 20 subject pilot phase, enrolled at one site (Mount Sinai). After completion of the pilot phase, the FDA will be provided with acute safety data (1 month). During the FDA's review of the pilot phase, enrollment may continue at the initial site. Also, IRB submissions at other prospective sites (up to a total of 10) may be initiated. Upon receipt of the go-ahead from FDA and after consultation with the study sponsor, the second phase of the study (to enroll 100 total subjects) will be performed. This research study currently has approval to enroll 25 patents. Should FDA grant approval to continue the study, the research team will expand as above and update this posting.

Inclusion Criteria:

- Age >18 years

- Long-standing Persistent AF (>1 year continuous AF)

- Planned for a first-ever AF ablation procedure

- Left ventricular ejection fraction >30% (as assessed within 6 months of randomization)

Exclusion Criteria:

- Prior left atrial ablation or left atrial surgery (including mitral valve surgery)

- Hypertrophic cardiomyopathy

- Major cardiac surgery within 6 months preceding the consent date

- Within 3 months preceding the consent date:

- Stroke, TIA, intracranial bleeding

- Any thromboembolic event

- Carotid stenting or endarterectomy

- Life expectancy less than one year

Conditions:
• Atrial Fibrillation