Actively Recruiting
Pulsed-field Ablation Vs. Sham Ablation to Treat AF
Led by Charles University, Czech Republic · Updated on 2025-01-22
60
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
Sponsors
C
Charles University, Czech Republic
Lead Sponsor
N
Na Homolce Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Pulsed-field Ablation Vs. Sham Ablation to Treat AF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Diagnosis of paroxysmal or persistent atrial fibrillation (not long-standing persistent AF)
- Atrial Fibrillation Effect on QualiTy of life (AFEQT) score of 50 or less at screening
You will not qualify if you...
- Any prior atrial fibrillation or left atrial ablation procedure
- Untreated other arrhythmias such as atrial flutter, supraventricular tachycardia, ventricular tachycardia, or frequent premature ventricular contractions
- Long-standing persistent atrial fibrillation lasting more than 1 year
- Permanent atrial fibrillation
- No ECG evidence of an atrial fibrillation episode lasting more than 30 seconds in the 6 months before randomization
- Left atrium size greater than 55 mm
- Hypertrophic cardiomyopathy
- Any aortic stenosis or moderate to severe mitral valve regurgitation
- Left ventricular ejection fraction 35% or less within 6 months before randomization
- Moderate or severe pulmonary hypertension
- History of tachycardia-induced cardiomyopathy
- Symptomatic coronary artery disease
- Pregnancy
- Presence of an artificial heart valve
- Life expectancy less than 2 years
- Any known medical condition or contraindication that could cause complications for procedures or follow-up
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cardiocenter, University Hospital Kralovske Vinohrady
Prague, Czechia, 10034
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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