NCT06128174Completed
LS-PersAFone: Pulsed Field Ablation for Long-Standing Persistent Atrial Fibrillation
Pulsed Field Ablation for Long-Standing Persistent Atrial Fibrillation (LS-PersAFone)
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 7 Nov 2023
- Start date
- 23 Jan 2024
- Primary completion date
- 24 Nov 2025
- Lead sponsor
- Vivek Reddy
- Diseases
- Atrial fibrillation
- NCT number
- NCT06128174
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 23 Jan 2024 to the primary completion date, 24 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior left atrial ablation or left atrial surgery (including mitral valve surgery)
Other illness
- 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
Other
- Hypertrophic cardiomyopathy
- Life expectancy less than one year
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.