Pulsed-field Ablation Vs. Sham Ablation to Treat AF
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Atrial Fibrillation
In brief
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 approximately 20-30 min of anesthesia with propofol and benzodiazepines in a similar manner as patients in the ablation arm. Primary endpoints will be assessed six months after the procedure. ECGs will be monitored using implantable ECG monitors (ILR) in all patients. There will be two co-primary endpoints (assessed at six months or at cross-over if Early Exit): 1. Freedom from recurrent AF/AT/AFL (post 2-month blanking), assessed as time-to first recurrence; 2. Quality of life according to Atrial Fibrillation Effect on QualiTy of life (AFEQT) score at 6 months (or at cross-over if Early Exit).
Key facts
- Study ID
- NCT05717725
- Run by
- Charles University, Czech Republic
- People needed
- 60
- Starts
- 2023-09-27
- Expected to finish
- 2026-02-28
- Last updated by the study team
- 2025-01-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age >18 years;
- Paroxysmal or Persistent Atrial Fibrillation (but not long-standing Persistent AF);
- AFEQT score ≤ 50.
You may not qualify if…
- Any prior AF ablation procedure (or left atrial ablation procedure)
- Untreated other arrhythmias (e.g. atrial flutter, SVT, VT, frequent PVCs);
- Long-standing Persistent AF episodes (any continuous episodes lasting > 1 year);
- Permanent AF;
- No ECG evidence of AF episode >30 seconds in the 6 months prior to randomization;
- LA size > 55 mm;
- Hypertrophic cardiomyopathy;
- Valve disease (any aortic stenosis, moderate or severe mitral regurgitation);
- Left ventricular ejection fraction ≤ 35% according to echocardiogram within 6 months of randomization;
- Moderate or severe pulmonary hypertension;
- History of tachycardia-induced cardiomyopathy;
- Symptomatic coronary artery disease;
- Pregnancy;
- Presence of an artificial valve;
- Life expectancy less than two years;
- Known medical condition or contraindication causing potential complications for interventional procedures or follow up.
Where it is running
- Cardiocenter, University Hospital Kralovske Vinohrady — Prague, Czechia (enrolling)
Full record on ClinicalTrials.gov
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