Pulsed-field Ablation Vs. Sham Ablation to Treat AF

NCT05717725 | Recruiting Phase 3 DMC

• 1 other identifier: PFA SHAM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 1.Freedom from recurrent AF/AT/AFL (post 2-month blanking), assessed as time-to first recurrence;
2. 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

Atrial Fibrillation

Keywords

atrial fibrillation; catheter ablation; pulsed-field ablation; quality of life

Outcome Measures

Primary Outcomes (2)

• AF freedom

  Freedom from recurrent AF/AT/AFL (post two month blanking period): assessed as time to first recurrence (or to cross-over)

  6 months

• Quality of life

  Quality of life according to the Atrial Fibrillation Effect on QualiTy of life (AFEQT) score at six months post ablation (or at cross-over for Early Exits) AFEQT is a 20-item questionnaire that asks about the degree to which different AF-related symptoms, treatment effects, and satisfaction with treatment have affected the patient over the past 4 weeks. The range is from 0 to 100. Lower scores indicate higher AF severity.

  6 months

Secondary Outcomes (6)

• AF burden

  6 months

• Hospital Anxiety and Depression Score

  6 months

• 12-month Freedom from recurrent AF

  12 months

• 12-month differences in quality of life

  12 months

• Unplanned Cardiovascular Hospitalization

  12 month

Study Arms (2)

Pulsed-field ablation arm

ACTIVE COMPARATOR

Patients will undergo catheter ablation using for atrial fibrillation using pulsed-field energy

Procedure: Pulsed-field ablation

Sham procedure arm

SHAM COMPARATOR

Patients will receive sham procedure (no ablation)

Procedure: Sham procedure

Interventions

Pulsed-field ablation PROCEDURE

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

Pulsed-field ablation arm

Sham procedure PROCEDURE

Patients will receive sham procedure, no ablation.

Sham procedure arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years;
• Paroxysmal or Persistent Atrial Fibrillation (but not long-standing Persistent AF);
• AFEQT score ≤ 50.

You may not qualify if:

• Any prior AF ablation procedure (or left atrial ablation procedure)
• Untreated other arrhythmias (e.g. atrial flutter, SVT, VT, frequent PVCs);
• Long-standing Persistent AF episodes (any continuous episodes lasting \> 1 year);
• Permanent AF;
• No ECG evidence of AF episode \>30 seconds in the 6 months prior to randomization;
• LA size \> 55 mm;
• Hypertrophic cardiomyopathy;
• Valve disease (any aortic stenosis, moderate or severe mitral regurgitation);
• Left ventricular ejection fraction ≤ 35% according to echocardiogram within 6 months of randomization;
• Moderate or severe pulmonary hypertension;
• History of tachycardia-induced cardiomyopathy;
• Symptomatic coronary artery disease;
• Pregnancy;
• Presence of an artificial valve;
• Life expectancy less than two years;

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Na Homolce Hospital: collaborator
• Nemocnice AGEL Trinec-Podlesi a.s.: collaborator
• Neuron Medical s.r.o.: collaborator

Study Sites (1)

Cardiocenter, University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of the dept. of cardiac arrhythmias

Model Details: Patients will be randomized to pulsed-field ablation or sham procedure.

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: February 8, 2023
• Study Start: September 27, 2023
• Primary Completion: September 1, 2025
• Study Completion: February 28, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

CZ (1)