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Pulsed-field Ablation Vs. Sham Ablation to Treat AF

RecruitingPhase 3Ages 18 Years - anyAllCharles University, Czech Republic
NCT05717725 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The study is planned as a single-blind, multicenter, prospective, randomized study. Sixty sbjects will be randomized 1:1 to either: (i) EP study + PFA, or (ii) EP study + Sham ablation control. After informed consent is obtained, an implantable loop recorder (ILR) will be implanted within seven days, and an EP study will be scheduled for 30±5 days after ILR implantation. Patients in both groups will first undergo an EP study to rule out a concealed AV bypass tract and supraventricular tachycardia (SVT). Patients will not be randomized if SVT or concealed AV bypass tract is found during the EP study. Once an SVT or bypass tract is excluded, randomization will be performed. Patients randomized to Ablation will undergo PVI using the commercially-available pentaspline PFA catheter (Farawave, Farapulse-BSCI Inc). Patients randomized to the Sham-ablation Control group will simply undergo app

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📋 Eligibility rules (as published)
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.
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What it tests

  • Pulsed-field ablation
  • Sham procedure
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Where

1 site
Cardiocenter, University Hospital Kralovske Vinohrady
Prague, Czechia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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