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Taking people in CzechiaPhase 3

Pulsed-field ablation compared with a sham procedure for atrial fibrillation

Tests pulsed-field ablation against a sham procedure in adults with atrial fibrillation.

Key facts

Who runs it
Charles University, Czech Republic
Where
Prague, CzechiaSee the site
Trial code
Registry title
Pulsed-field Ablation Vs. Sham Ablation to Treat AF
Status
Recruiting
Phase
Phase 3
People taking part
60 people, planned
Started
27 Sept 2023
Planned end
28 Feb 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Pulsed-field ablation
  • Sham procedure
Record updated
22 January 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with paroxysmal or persistent atrial fibrillation and a low quality-of-life score. Half get pulsed-field ablation, half get a sham (pretend) procedure.

Age
Over 18 years
Sex
All sexes can join.
Disease stage
Paroxysmal or persistent atrial fibrillation, but not long-standing persistent atrial fibrillation. An AF episode longer than 30 seconds on ECG in the 6 months before randomization.
Earlier treatment
No earlier AF ablation or left atrial ablation.
Biomarker or test result
AFEQT quality-of-life score of 50 or lower.

Main reasons for not taking part

  • Long-standing persistent or permanent atrial fibrillation
  • Untreated other heart rhythm problems such as atrial flutter, SVT or VT
  • Left atrium larger than 55 mm, or left ventricular ejection fraction of 35% or lower
  • Hypertrophic cardiomyopathy, valve disease or an artificial valve
  • Pregnancy, or life expectancy under two years

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

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

Who cannot take part

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

Where in Czechia

  • Cardiocenter, University Hospital Kralovske VinohradyPrague, CzechiaContact: Pavel Osmancik, MD, PhDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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).

The 2 groups in the trial

  • Pulsed-field ablation armExisting treatment, for comparison

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

    Treatment: Pulsed-field ablation

  • Sham procedure armSham treatment, for comparison

    Patients will receive sham procedure (no ablation)

    Treatment: Sham procedure

Results explained

A paper that names this trial, explained in plain words.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Pulsed-field Ablation Versus Sham Ablation to Treat Atrial Fibrillation
Plain-language title
Pulsed-field ablation compared with a sham procedure for atrial fibrillationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
22 January 2025