CompletedNot Applicable

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

United States20 participantsStarted 2024-01-23

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with freedom from recurrent atrial arrhythmias

Timeframe: post 3 month blanking period till end of study at 12 months

Trial details

NCT IDNCT06128174

SponsorVivek Reddy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-24

View on ClinicalTrials.gov More Long-standing Persistent AF trials