Comparing pulsed-field ablation to a sham procedure for treating atrial fibrillation
Pulsed-field Ablation Versus Sham Ablation to Treat Atrial Fibrillation
This study is testing whether a new treatment called pulsed-field ablation can help people with atrial fibrillation feel better and improve their quality of life compared to a fake procedure.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charles University, Czech Republic Academic / other |
| Locations | 1 site (Prague) |
| Trial ID | NCT05717725 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with symptomatic paroxysmal or persistent atrial fibrillation and an AFEQT score of 50 or lower.
Not a fit: Patients with long-standing persistent atrial fibrillation, untreated other arrhythmias, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from atrial fibrillation, potentially leading to improved symptom management and quality of life.
How similar studies have performed: Other studies have shown promising results with catheter ablation techniques for atrial fibrillation, suggesting that this approach may be effective, although pulsed-field ablation specifically is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Prague
- Cardiocenter, University Hospital Kralovske Vinohrady — Prague, Czechia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.