Comparing pulsed-field ablation to a sham procedure for treating atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a single-blind, multicenter, prospective, randomized study designed to evaluate the efficacy of pulsed-field ablation (PFA) compared to a sham ablation procedure in patients with symptomatic paroxysmal or persistent atrial fibrillation (AF). A total of sixty subjects will be randomized to receive either PFA or sham treatment after undergoing an electrophysiology (EP) study to rule out other arrhythmias. The primary outcomes include freedom from recurrent AF and quality of life improvements measured by the AFEQT score at six months post-procedure. The study aims to provide insights into the effectiveness of PFA in managing AF symptoms and improving patient quality of life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \>18 years;
2. Paroxysmal or Persistent Atrial Fibrillation (but not long-standing Persistent AF);
3. AFEQT score ≤ 50.

Exclusion Criteria:

1. Any prior AF ablation procedure (or left atrial ablation procedure)
2. Untreated other arrhythmias (e.g. atrial flutter, SVT, VT, frequent PVCs);
3. Long-standing Persistent AF episodes (any continuous episodes lasting \> 1 year);
4. Permanent AF;
5. No ECG evidence of AF episode \>30 seconds in the 6 months prior to randomization;
6. LA size \> 55 mm;
7. Hypertrophic cardiomyopathy;
8. Valve disease (any aortic stenosis, moderate or severe mitral regurgitation);
9. Left ventricular ejection fraction ≤ 35% according to echocardiogram within 6 months of randomization;
10. Moderate or severe pulmonary hypertension;
11. History of tachycardia-induced cardiomyopathy;
12. Symptomatic coronary artery disease;
13. Pregnancy;
14. Presence of an artificial valve;
15. Life expectancy less than two years;
16. Known medical condition or contraindication causing potential complications for interventional procedures or follow up.

Where it's running

• Cardiocenter, University Hospital Kralovske Vinohrady
  Prague, Czechia Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.