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Pulsed-field Ablation Vs. Sham Ablation to Treat AF

NCT05717725 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-01-22

No results posted yet for this study

Summary

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

Interventions

PROCEDURE

Pulsed-field ablation

Patients will receive catheter ablation, i.e. pulmonary vein isolation by means of pulsed-field energy

PROCEDURE

Sham procedure

Patients will receive sham procedure, no ablation.

Sponsors & Collaborators

  • Na Homolce Hospital

    collaborator OTHER

  • Nemocnice AGEL Trinec-Podlesi a.s.

    collaborator OTHER

  • Neuron Medical s.r.o.

    collaborator UNKNOWN

  • Charles University, Czech Republic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-27
Primary Completion
2025-09-01
Completion
2026-02-28

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05717725 on ClinicalTrials.gov