Pulsed-field Ablation Vs. Sham Ablation to Treat AF
Recruiting
Phase 3
Interventional Study
Atrial Fibrillation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Charles University, Czech Republic · Other
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 …
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
1. Age \>18 years;
2. Paroxysmal or Persistent Atrial Fibrillation (but not long-standing Persistent AF);
3. AFEQT score ≤ 50.
Exclusion Criteria:
1. Any prior AF ablation procedure (or left atrial ablation procedure)
2. Untreated other arrhythmias (e.g. atrial flutter, SVT, V…
Contacts
No contact information available.