Pulsed-field Ablation Vs. Sham Ablation to Treat AF
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 wi
| Condition(s) | Atrial Fibrillation |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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, F |
| Who can participate | 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. Histo |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Charles University, Czech Republic |
| Locations | Prague, Czechia |
| Start date | 2023-09-27 |
| NCT ID | NCT05717725 |
| Official listing | https://clinicaltrials.gov/study/NCT05717725 |