NCT05717725RecruitingPhase 3
Pulsed-field Ablation Vs. Sham Ablation to Treat AF
Pulsed-field Ablation Versus Sham Ablation to Treat Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 22 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 31 Oct 2022
- Start date
- 27 Sept 2023
- Primary completion date
- 1 Sept 2025
- Lead sponsor
- Charles University, Czech Republic
- Diseases
- Atrial fibrillation
- NCT number
- NCT05717725
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 60
- From 27 Sept 2023 to the primary completion date, 1 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior AF ablation procedure (or left atrial ablation procedure)
- No ECG evidence of AF episode \>30 seconds in the 6 months prior to randomization;
Other illness
- Untreated other arrhythmias (e.g. atrial flutter, SVT, VT, frequent PVCs);
- Valve disease (any aortic stenosis, moderate or severe mitral regurgitation);
- Moderate or severe pulmonary hypertension;
- History of tachycardia-induced cardiomyopathy;
- Symptomatic coronary artery disease;
- Known medical condition or contraindication causing potential complications for interventional procedures or follow up.
Lab values
- Left ventricular ejection fraction ≤ 35% according to echocardiogram within 6 months of randomization;
Other
- Long-standing Persistent AF episodes (any continuous episodes lasting \> 1 year);
- Permanent AF;
- LA size \> 55 mm;
- Hypertrophic cardiomyopathy;
- Pregnancy;
- Presence of an artificial valve;
- Life expectancy less than two years;
Who the study is looking for
- Age \>18 years;
- Paroxysmal or Persistent Atrial Fibrillation (but not long-standing Persistent AF);
- AFEQT score ≤ 50.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiocenter, University Hospital Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
Related publications
- Pulsed Field Ablation Versus Sham to Treat Atrial Fibrillation: The PFA-SHAM Randomized Clinical Trial.Circulation · 2026 · PMID 42186803
This page is information, not medical advice. Discuss any trial with your doctor.