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NCT07745543

Redo-Pulmonary Vein Isolation With Versus Without Posterior Wall Ablation - The REDO-PIFPAF-PFA Study

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

Summary

The study will compare two ablation strategies in patients with paroxysmal or persistent atrial fibrillation undergoing repeat ablation using pulsed-field ablation: redo pulmonary vein isolation only versus redo pulmonary vein isolation with added posterior wall ablation.

Official title: Redo-Pulmonary Vein Isolation Using Pulsed-Field Ablation With Versus Without Posterior Wall Ablation in Patients With Symptomatic Atrial Fibrillation: A Multi-Centre Randomized Clinical Trial: The REDO-PIFPAF-PFA Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

270

Start Date

2026-08

Completion Date

2031-07

Last Updated

2026-08-04

Healthy Volunteers

Conditions

Atrial Fibrillation (AF)

Interventions

PROCEDURE

Pulmonary vein isolation with posterior wall ablation

Redo-pulmonary vein isolation with left atrial posterior wall ablation using pulsed-field ablation technology. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring.

PROCEDURE

Pulmonary vein isolation without posterior wall ablation

Redo-pulmonary vein isolation without left atrial posterior wall ablation using pulsed-field ablation technology. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring.

Inclusion Criteria: 1. Documented recurrence of paroxysmal or persistent AF following single prior catheter ablation with PVI, confirmed by 12-lead ECG, Holter monitoring, or ICM within the last 2 years. 2. Candidate for repeat catheter ablation according to current European Society of Cardiology (ESC) AF management guidelines. 3. Continuous oral anticoagulation with a vitamin K antagonist or non-vitamin K oral anticoagulant (NOAC) for ≥ 4 weeks prior to the ablation, or transoesophageal echocardiography (TEE) and/or cardiac computed tomography (CT) within 48 hours before the procedure excluding LA thrombus. 4. Age ≥ 18 years at the time of informed consent. 5. Written informed consent obtained prior to any study-related procedures. Exclusion Criteria: 1. Previous LA surgery 2. \> 1 prior LA ablation 3. LA ablation outside of the PVs in the first LA ablation 4. LA diameter \>60 mm in the parasternal long axis 5. Patients in persistent AF lasting \>3 years 6. AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery) 7. Pre-existing PV stenosis or PV 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 procedure 15. Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including a patent foramen ovale) 16. New York Heart Association (NYHA) class III or IV congestive heart failure 17. Left ventricular ejection fraction (LVEF) \<35% 18. Hypertrophic cardiomyopathy or left septal 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. Cardiac amyloidosis 24. Pregnancy (to exclude pregnancy a blood test (HCG) is performed in women \< 50 years before inclusion) 25. Life expectancy less than one year per physician opinion 26. Currently participating in any other clinical trial, which may confound the results of this trial. 27. Unwilling or unable to comply fully with the study procedures and FU.

Locations (5)

University Hospital Basel

Basel, Switzerland

Bern University Hospital

Bern, Switzerland

University Hospital Lausanne

Lausanne, Switzerland

Cantonal Hospital of St. Gallen

Sankt Gallen, Switzerland

University Hospital Zurich,

Zurich, Switzerland