The PIFPAF-PFA Study

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: Pulmonary vein isolation without posterior wall ablation; Procedure: Pulmonary vein isolation with posterior wall ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05986526

2023-00885

Details and patient eligibility

About

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.

Enrollment: 206 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Persistent atrial fibrillation documented on a 12 lead ECG, Holter monitor or implantable cardiac device within last 2 years of enrollment
2. Persistent atrial fibrillation is defined as a sustained episode lasting > 7 days
3. Candidate for ablation based on current atrial fibrillation guidelines
4. 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
5. Age of 18 years or older on the date of informed consent
6. Signed informed consent

Exclusion criteria

1. Previous left atrial ablation or left atrial surgery
2. Left atrial diameter >60 mm in the parasternal long axis
3. Patients with paroxysmal atrial fibrillation
4. Patients with persistent atrial fibrillation lasting >3 years
5. AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)
6. Intracardiac thrombus
7. Pre-existing pulmonary vein stenosis or pulmonary vein stent
8. Pre-existing hemidiaphragmatic paralysis
9. Contraindication to anticoagulation or radiocontrast materials
10. Prior mitral valve surgery
11. Severe mitral regurgitation or moderate/severe mitral stenosis
12. Myocardial infarction during the 3-month period preceding the consent date
13. Ongoing triple antithrombotic/anticoagulation therapy
14. Cardiac surgery during the 3-month interval preceding the informed consent date or scheduled cardiac surgery/ transcatheter aortic valve implantation
15. Significant congenital heart defect (including atrial septal defects or pulmonary vein abnormalities but not including a patent foramen ovale)
16. NYHA class III or IV congestive heart failure
17. Left ventricular ejection fraction (LVEF) <35%
18. Hypertrophic cardiomyopathy (wall thickness >1.5 cm)
19. Significant chronic kidney disease (eGFR <30 ml/min)
20. Uncontrolled hyperthyroidism
21. Cerebral ischemic event (stroke or TIA) during the 6-month interval preceding the informed consent date
22. Ongoing systemic infections
23. History of cryoglobulinemia
24. Cardiac amyloidosis
25. Pregnancy (to exclude pregnancy a blood test (HCG) is performed in women < 50 years before inclusion)
26. Life expectancy less than one year per physician opinion
27. Currently participating in any other clinical trial, which may confound the results of this trial
28. Unwilling or unable to comply fully with the study procedures and follow-up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

Pulmonary vein isolation without posterior wall ablation

Active Comparator group

Description:

Pulmonary vein isolation without left atrial posterior wall ablation

Treatment:

Procedure: Pulmonary vein isolation without posterior wall ablation

Pulmonary vein isolation with posterior wall ablation

Active Comparator group

Description:

Pulmonary vein isolation with left atrial posterior wall ablation

Treatment:

Procedure: Pulmonary vein isolation with posterior wall ablation