CompletedNot Applicable

Ground-Breaking Electroporation-based Intervention for PERSistent Atrial Fibrillation Treatment (BEAT PERS-AF)

Austria, Belgium, Czechia83 participantsStarted 2022-11-04

Plain-language summary

BEAT AF is a randomized controlled trial aiming to assess the efficacy and the safety of pulsed field energy in persistent AF ablation

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

. Patients with drug-resistant symptomatic persistent AF meeting all the following criteria:
. Persistent: continuous drug resistant AF that is sustained beyond 7 days (but less than 1 year).
. Frequency: At least one (1) documented episode by a recording such as ECG, EM, Holter monitor or telemetry strip within 6 months of enrolment.
. Drug failed: Failed AAD treatment, meaning therapeutic failure of at least one (1) AAD (Class I to IV) for efficacy and / or intolerance.
. Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
. Patient who are willing and capable of:
. Providing informed consent to undergo study procedures AND
. Participating in all examinations and follow-up visits and tests associated with this clinical study.

Exclusion criteria

. Paroxysmal AF by diagnosis or that terminates spontaneously within 7 days of onset
. Secondary to electrolyte imbalance, thyroid disease, alcohol or other reversible / non-cardiac causes 2. Any of the following atrial conditions:

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

proportion of subjects experiencing 1-year single-procedure clinical success

Timeframe: 1 year

Trial details

NCT IDNCT05418725

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-28

View on ClinicalTrials.gov More Atrial Fibrillation trials