Status:
ACTIVE_NOT_RECRUITING
The PIFPAF-PFA Study
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Persistent Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 abla...
Eligibility Criteria
Inclusion
- 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
- Previous left atrial ablation or left atrial surgery
- Left atrial diameter \>60 mm in the parasternal long axis
- Patients with paroxysmal atrial fibrillation
- Patients with persistent atrial fibrillation lasting \>3 years
- AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)
- Intracardiac thrombus
- Pre-existing pulmonary vein stenosis or pulmonary vein stent
- Pre-existing hemidiaphragmatic paralysis
- Contraindication to anticoagulation or radiocontrast materials
- Prior mitral valve surgery
- Severe mitral regurgitation or moderate/severe mitral stenosis
- Myocardial infarction during the 3-month period preceding the consent date
- Ongoing triple antithrombotic/anticoagulation therapy
- 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
- Left ventricular ejection fraction (LVEF) \<35%
- Hypertrophic cardiomyopathy (wall thickness \>1.5 cm)
- Significant chronic kidney disease (eGFR \<30 ml/min)
- Uncontrolled hyperthyroidism
- Cerebral ischemic event (stroke or TIA) during the 6-month interval preceding the informed consent date
- Ongoing systemic infections
- History of cryoglobulinemia
- Cardiac amyloidosis
- Pregnancy (to exclude pregnancy a blood test (HCG) is performed in women \< 50 years before inclusion)
- 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
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2028
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT05986526
Start Date
November 13 2023
End Date
February 13 2028
Last Update
February 18 2025
Active Locations (6)
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1
Cantonal Hospital Baden
Baden, Switzerland
2
University Hospital Basel
Basel, Switzerland
3
Inselspital, University Hospital Bern
Bern, Switzerland, 3010
4
University Hospital Lausanne
Lausanne, Switzerland, 1011