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

Study Summary

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.

Primary Outcome

Number of participants with freedom from recurrent atrial arrhythmias (AF/AT/AFL) (post 3-month blanking), assessed as time to first recurrence. AF/AT/AFL will be defined as an episode of the corresponding arrhythmia that is recorded for review, where the recording contains at least 30 seconds of continuous interpretable signal. An exception is a 12-lead ECG where the arrhythmia occurs during the entire tracing and the continuous interpretable signal is 10 seconds or longer.

Interventions

• DEVICE Farawave PFA catheter