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New treatment option for Atrial Fibrillation
Official title Pulsed-field Ablation Vs. Sham Ablation to Treat AF
ClinicalTrials.gov ID: NCT05717725
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \>18 years;
- Paroxysmal or Persistent Atrial Fibrillation (but not long-standing Persistent AF);
- AFEQT score ≤ 50.
You likely can't join 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;
See the full eligibility criteria
- Age \>18 years;
- Paroxysmal or Persistent Atrial Fibrillation (but not long-standing Persistent AF);
- AFEQT score ≤ 50.
- 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;
- Known medical condition or contraindication causing potential complications for treatment procedures or follow up.
The study team makes the final eligibility decision.
Where it's taking place
- Prague, Czechia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Prague, Czechia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.