Pulsed-field Ablation Vs. Sham Ablation to Treat AF

Sponsor
Charles University, Czech Republic
Study ID
NCT05717725
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pulsed-field ablation — PROCEDURE
    Patients will receive catheter ablation, i.e. pulmonary vein isolation by means of pulsed-field energy
  • Sham procedure — PROCEDURE
    Patients will receive sham procedure, no ablation.

Study Details

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 Dates

Start date
Sep 27, 2023
Status verified
Jan 2025
Primary completion
Sep 1, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pulsed-field ablation arm
    Patients will undergo catheter ablation using for atrial fibrillation using pulsed-field energy
  • Sham Comparator: Sham procedure arm
    Patients will receive sham procedure (no ablation)

Primary Outcome Measure

AF freedom [ Time Frame: 6 months ]

Related Studies