The PIFPAF-PFA Study (NCT05986526) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The PIFPAF-PFA Study
Switzerland206 participantsStarted 2023-11-13
Plain-language summary
Pulmonary vein isolation (PVI) is very effective for rhythm control in patients with paroxysmal atrial fibrillation (AF), but less successful in patients with persistent AF. Adding posterior wall ablation (PWA) to PVI is among the most promising ablation strategies to improve arrhythmiafree outcome in patients with persistent AF. Patients with left atrial posterior wall scar may benefit most from adding PWA to PVI. With previous ablation technology, posterior wall isolation (PWI) was difficult to achieve and increased the risk of procedural complications. With pulsed-field ablation (PFA), a technology is now available which is both very effective and safe for complete ablation of the posterior wall. The aim of this trial therefore is to compare the efficacy and procedural safety of two ablation strategies for the treatment of persistent AF using PFA: PVI only versus PVI with added PWA. The endpoint of atrial arrhythmia recurrence within 12 months will be assessed by an implantable cardiac monitor (ICM) with remote monitoring capabilities.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Persistent atrial fibrillation documented on a 12 lead ECG, Holter monitor or implantable cardiac device within last 2 years of enrollment
✓. Persistent atrial fibrillation is defined as a sustained episode lasting \> 7 days
✓. Candidate for ablation based on current atrial fibrillation guidelines
✓. Continuous anticoagulation with Vitamin-K-Antagonists or a NOAC for ≥4 weeks prior to the ablation; or a transesophageal echocardiography and/or CT scan that excludes left atrial thrombus ≤48 hours before the ablation procedure
✓. Age of 18 years or older on the date of informed consent
✓. Signed informed consent
Exclusion criteria
✕. Previous left atrial ablation or left atrial surgery
✕. Left atrial diameter \>60 mm in the parasternal long axis
✕. Patients with paroxysmal atrial fibrillation
What they're measuring
1
Time to first recurrence of any atrial tachyarrhythmia