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

N/ANot Yet RecruitingNCT07745543

University Hospital, Basel, Switzerland270 enrolled

Overview

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.

In most patients, recurrence after ablation is caused by reconnection of previously isolated pulmonary veins (PV). However, atrial fibrillation (AF) recurrence may also result from progressive atrial remodelling, structural disease progression, and triggers originating outside the PVs. While there are multiple randomized controlled trials and clear recommendations for de novo ablations, there is a notable lack of studies and guideline recommendations for redo ablation procedures. Current practice therefore remains heterogeneous, and optimal lesion sets in the redo setting are not defined. The study aims to address this deficiency by undertaking a randomised comparison of two strategies that have already been adopted.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

270

Conditions

Atrial Fibrillation (AF)

Interventions

Pulmonary vein isolation with posterior wall ablationPROCEDURE

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.

Pulmonary vein isolation without posterior wall ablationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time to first recurrence of any atrial tachyarrhythmia day 61-365

Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation (AF), atrial flutter (AFL) or atrial tachycardia (AT)) between day 61 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will be defined as an episode of at least 120 seconds (the shortest-duration episode that could be programmed for detection on the implantable cardiac monitor) with a continuous atrial arrhythmia of at least 30 seconds.

Time frame: Day 61-365 post-ablation

Secondary Outcomes

Treatment-emergent adverse events: Cardiac tamponade requiring drainage

Number of patients with cardiac tamponade requiring drainage after PVI

Time frame: Day 0-90 post-ablation

Treatment-emergent adverse events: Persistent phrenic nerve palsy lasting >24 hours

Number of patients with persistent phrenic nerve palsy lasting \>24 hours after PVI

Time frame: Day 0-90 post-ablation

Treatment-emergent adverse events: Serious vascular complication requiring intervention

Number of patients with serious vascular complications requiring intervention after PVI

Time frame: Day 0-90 post-ablation

Treatment-emergent adverse events: Stroke or TIA

Number of patients with stroke or TIA after PVI

Time frame: Day 0-90 post-ablation

Treatment-emergent adverse events: Atrioesophageal fistula

Number of patients with atrioesophageal fistula after PVI

Time frame: Day 0-90 post-ablation

Central Contacts

Patrick Badertscher, PD Dr. med.

CONTACT

+4161 556 58 23 patrick.badertscher@usb.ch

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

University Hospital Zurich,

Treatment-emergent adverse events: Death

Number of patients with fatal outcome/death after PVI

Time frame: Day 0-90 post-ablation

Total procedure time

Procedural endpoint; \[min\]

Time frame: Day 0, during procedure

Total left atrial indwelling time

Procedural endpoint; \[min\]

Time frame: Day 0, during procedure

Total fluoroscopy time

Procedural endpoint; \[min\]

Time frame: Day 0, during procedure

Total radiation dose

Procedural endpoint; Calculated by multiplying the absorbed radiation dose (air kerma) by the cross-sectional area of the X-ray beam \[cG\*cm2\]

Time frame: Day 0, during procedure

Change in hs-troponin on Day 1 post-ablation compared with pre-procedural hs-troponin

Procedural endpoint; \[ng/L\]

Time frame: Pre-procedural (day -1 or day 0) to day 1 post-ablation

Post-ablation 3D-EAM: Assessment of atrial low-voltage/scar

Procedural endpoint; Presence and extend of atrial low-voltage/scar will be assessed on 3D-EAM (three dimensional electroanatomical mapping.). Low-voltage areas will be identified on the basis of bipolar voltage mapping according to pre-specified mapping settings (rhythm during mapping, catheter type, point density, filtering) and recorded as (i) presence/absence and (ii) quantified surface area (cm²) within predefined left atrial regions (including posterior wall; optional: anterior wall; overall left atrium).

Time frame: Day 0, shortly after ablation

Post-ablation 3D-EAM: Proportion of isolated veins

Procedural endpoint

Time frame: Day 0, shortly after ablation

Post-ablation 3D-EAM: Proportion of isolated carinas

Procedural endpoint

Time frame: Day 0, shortly after ablation

Post-ablation 3D-EAM: Lesion size

Procedural endpoint

Time frame: Day 0, shortly after ablation

Post-ablation 3D-EAM: Posterior wall ablation success rate

Procedural endpint; experimental group only

Time frame: Day 0, shortly after ablation

Time to first recurrence of any atrial tachyarrhythmia in patients with left atrial posterior wall scar and posterior wall ablation versus without posterior wall ablation