The PIFPAF-PFA Study

NCT ID: NCT05986526

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-13
• Study Completion Date: 2028-02-13

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 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.

Conditions

Persistent Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pulmonary vein isolation without posterior wall ablation

Pulmonary vein isolation without left atrial posterior wall ablation

Group Type: ACTIVE_COMPARATOR

Pulmonary vein isolation without posterior wall ablation

Intervention Type: PROCEDURE

Pulmonary vein isolation with Pulsed field ablation without left atrial posterior wall ablation. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring

Pulmonary vein isolation with posterior wall ablation

Pulmonary vein isolation with left atrial posterior wall ablation

Group Type: ACTIVE_COMPARATOR

Pulmonary vein isolation with posterior wall ablation

Intervention Type: PROCEDURE

Pulmonary vein isolation with Pulsed field ablation with left atrial posterior wall ablation. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring

Interventions

Pulmonary vein isolation without posterior wall ablation

Pulmonary vein isolation with Pulsed field ablation without left atrial posterior wall ablation. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring

Intervention Type: PROCEDURE

Pulmonary vein isolation with posterior wall ablation

Pulmonary vein isolation with Pulsed field ablation with left atrial posterior wall ablation. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent Roten, MD

Role: PRINCIPAL_INVESTIGATOR

Inselspital, University Hospital Bern

Locations

Cantonal Hospital Baden

Baden, , Switzerland

University Hospital Basel

Basel, , Switzerland

Inselspital, University Hospital Bern

Bern, , Switzerland

University Hospital Lausanne

Lausanne, , Switzerland

Cantonal Hospital St. Gallen

Sankt Gallen, , Switzerland

University Hospital Zürich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2023-00885

Identifier Type: -

Identifier Source: org_study_id