Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05717725 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Pulsed-field Ablation Vs. Sham Ablation to Treat AF

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 22, 2025 (before its estimated September 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Phase: Not applicable to Phase 3
    • Primary completion date: Dec 1, 2024 to Sep 1, 2025
    • Study completion date: Dec 30, 2024 to Feb 28, 2026
    • Study description expanded, about 464 words
    v6
  2. Primary endpoints revised (2)
    • Secondary endpoints: 8 to 6
    • Study description shortened, about 639 words
    v5
  3. Secondary endpoints: details revised at 5 of 8 entriesv4
  4. Primary endpoints revised (2)
    • Eligibility criteria shortened, about 6 words
    • Study description expanded, about 339 words
    v3
  5. Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Primary completion date: May 1, 2024 to Dec 1, 2024
    • Start date: Apr 1, 2023 to Sep 27, 2023
    • Enrollment target: 50 to 60
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: 5 to 8
    • Study description expanded, about 1,441 words
    • Study site revised
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05717725
Lead Sponsor Charles University, Czech Republic
Collaborators: Na Homolce Hospital, Nemocnice AGEL Trinec-Podlesi a.s., Neuron Medical s.r.o.
Conditions
(from sponsor)		 Atrial Fibrillation
Related terms Atrial Fibrillation
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov