NCT05986526Active, not recruiting
The PIFPAF-PFA Study
Pulmonary Vein Isolation With Pulsed-Field Ablation With Versus Without Posterior Wall Ablation in Patients With Symptomatic Persistent Atrial Fibrillation - A Multi-Center Randomized Clinical Trial: The PIFPAF-PFA Study
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 206 (actual)
- First submitted
- 25 Jul 2023
- Start date
- 13 Nov 2023
- Primary completion date
- 13 Feb 2026
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Diseases
- Atrial fibrillation
- NCT number
- NCT05986526
What you commit to
- Study type: Interventional
- Participants enrolled: 206
- From 13 Nov 2023 to the primary completion date, 13 Feb 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous left atrial ablation or left atrial surgery
- AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)
- Prior mitral valve surgery
- Ongoing triple antithrombotic/anticoagulation therapy
Other illness
- Myocardial infarction during the 3-month period preceding the consent date
- Cardiac surgery during the 3-month interval preceding the informed consent date or scheduled cardiac surgery/ transcatheter aortic valve implantation
- Significant congenital heart defect (including atrial septal defects or pulmonary vein abnormalities but not including a patent foramen ovale)
- NYHA class III or IV congestive heart failure
- Cerebral ischemic event (stroke or TIA) during the 6-month interval preceding the informed consent date
- Ongoing systemic infections
- History of cryoglobulinemia
- Cardiac amyloidosis
Lab values
- Left ventricular ejection fraction (LVEF) \<35%
- Significant chronic kidney disease (eGFR \<30 ml/min)
Age
- Patients with persistent atrial fibrillation lasting \>3 years
- Pregnancy (to exclude pregnancy a blood test (HCG) is performed in women \< 50 years before inclusion)
Other
- Left atrial diameter \>60 mm in the parasternal long axis
- Patients with paroxysmal atrial fibrillation
- Intracardiac thrombus
- Pre-existing pulmonary vein stenosis or pulmonary vein stent
- Pre-existing hemidiaphragmatic paralysis
- Contraindication to anticoagulation or radiocontrast materials
- Severe mitral regurgitation or moderate/severe mitral stenosis
- Hypertrophic cardiomyopathy (wall thickness \>1.5 cm)
- Uncontrolled hyperthyroidism
- Life expectancy less than one year per physician opinion
- Currently participating in any other clinical trial, which may confound the results of this trial
- Unwilling or unable to comply fully with the study procedures and follow-up
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cantonal Hospital Baden Coordinator of this site? Confirm its status | Baden | Switzerland | Unknown status |
| University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Inselspital, University Hospital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| University Hospital Lausanne Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Cantonal Hospital St Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| University Hospital Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.