Atrial Fibrillation (AF)
Conditions
Keywords
Pulmonary vein isolation, Pulsed field albation, posterior wall ablation
Brief 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.
Detailed description
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.
Interventions
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.
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.
Sponsors
University Hospital, Basel, Switzerland
Swiss Heart Foundation
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The independent clinical events committee (CEC) will remain blinded to treatment allocation throughout endpoint adjudication.
Intervention model description
Multi-centre, randomized controlled superiority trial with a parallel cohort arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first recurrence of any atrial tachyarrhythmia day 61-365 | Day 61-365 post-ablation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent adverse events: Cardiac tamponade requiring drainage | Day 0-90 post-ablation | Number of patients with cardiac tamponade requiring drainage after PVI |
| Treatment-emergent adverse events: Persistent phrenic nerve palsy lasting >24 hours | Day 0-90 post-ablation | Number of patients with persistent phrenic nerve palsy lasting \>24 hours after PVI |
| Treatment-emergent adverse events: Serious vascular complication requiring intervention | Day 0-90 post-ablation | Number of patients with serious vascular complications requiring intervention after PVI |
| Treatment-emergent adverse events: Stroke or TIA | Day 0-90 post-ablation | Number of patients with stroke or TIA after PVI |
| Treatment-emergent adverse events: Atrioesophageal fistula | Day 0-90 post-ablation | Number of patients with atrioesophageal fistula after PVI |
| Treatment-emergent adverse events: Death | Day 0-90 post-ablation | Number of patients with fatal outcome/death after PVI |
| Total procedure time | Day 0, during procedure | Procedural endpoint; \[min\] |
| Total left atrial indwelling time | Day 0, during procedure | Procedural endpoint; \[min\] |
| Total fluoroscopy time | Day 0, during procedure | Procedural endpoint; \[min\] |
| Total radiation dose | Day 0, during procedure | Procedural endpoint; Calculated by multiplying the absorbed radiation dose (air kerma) by the cross-sectional area of the X-ray beam \[cG\*cm2\] |
| Change in hs-troponin on Day 1 post-ablation compared with pre-procedural hs-troponin | Pre-procedural (day -1 or day 0) to day 1 post-ablation | Procedural endpoint; \[ng/L\] |
| Post-ablation 3D-EAM: Assessment of atrial low-voltage/scar | Day 0, shortly after ablation | 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). |
| Post-ablation 3D-EAM: Proportion of isolated veins | Day 0, shortly after ablation | Procedural endpoint |
| Post-ablation 3D-EAM: Proportion of isolated carinas | Day 0, shortly after ablation | Procedural endpoint |
| Post-ablation 3D-EAM: Lesion size | Day 0, shortly after ablation | Procedural endpoint |
| Post-ablation 3D-EAM: Posterior wall ablation success rate | Day 0, shortly after ablation | Procedural endpint; experimental group only |
| 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 | up to 3 years | Secondary endpoint during follow-up |
| Arrhythmia burden for each participant between days 0-60 evaluated based on continuous ICM (Implantable cardiac monitor) | Day 0-60 post-ablation | Secondary endpoint during follow-up |
| Arrhythmia burden for each participant between days 61 and 365 evaluated based on continuous ICM | Day 61-365 post-ablation | Secondary endpoint during follow-up |
| Arrhythmia burden for each participant between days 365 until explantation or end of life (EOL) of the ICM | Day 365 post-ablation to explantation of ICM or end of life of ICM (up to 4 years after implantation of ICM) | Secondary endpoint during follow-up |
| Correlation of AF burden to symptoms and quality of life (QoL) changes | Day 0-365 post-ablation | Secondary endpoint during follow-up; Quality of life will be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes; Symptoms will be measured with the AFEQT (Atrial Fibrillation Effect on Quality-of-life) questionnaire where higher scores mean worse outcomes. |
| Reduction of AF burden by > 90% post ablation procedure | up to 3 years | Secondary endpoint during follow-up |
| Comparison of the prevalence of the type of arrhythmia recurrence during FU being atrial fibrillation or organized atrial arrhythmias (atrial flutter or atrial tachycardia) | up to 3 years | Secondary endpoint during follow-up |
| Time to first recurrence of atrial tachyarrhythmia between days 61 and 365 in patients with presence of scar on the posterior wall based on the pre-ablation voltage map versus patients with no scar on the posterior wall evaluated based on continuous ICM | up to 1 year | Secondary endpoint during follow-up |
| Prevalence of persistent or paroxysmal atrial fibrillation | up to 3 years | Secondary endpoint during follow-up |
| Average heart rate | Months 1, 2 and 3 post-ablation | Secondary endpoint during follow-up; as recorded by the ICM in months 1, 2 and 3 after ablation |
| Hospital or emergency room admission due to documented recurrence of atrial arrhythmias | up to 3 years | Incidence rate |
| Repeat ablation procedure due to documented recurrence of atrial arrhythmias | up to 3 years | Incidence rate |
| Reinitiation or continuation of antiarrhythmic drug therapy | up to 3 years | Incidence rate |
| Electrical cardioversion due to recurrence | up to 3 years | Incidence rate |
| Number of reconnected veins evaluated during redo procedures | During redo procedures between day 1 to 36 months post-ablation | Secondary endpoint during follow up; sites of reconnection and size of antral scar area evaluated during redo procedures |
| Number of reconnected posterior walls evaluated during redo procedures | During redo procedures between day 1 to 36 months post-ablation | Secondary endpoint during follow-up; sites of reconnection and size of the scar area evaluated during redo procedures |
| Evolution of QoL | Day 90 and day 365 post-ablation | The Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire is a 20-item, disease-specific tool used to measure how atrial fibrillation impacts a patient's daily life. Results are calculated on a scale from 0 (worst possible quality of life) to 100 (best possible quality of life). The EQ-5D-5L is a standardized, generic questionnaire used to measure health-related quality of life. The patient rates health on the current day across 5 areas: mobility, self-care; usual activities; Pain/discomfort; anxiety/depression. For each dimension, the patient chooses one of 5 severity levels: No problems;Slight problems;Moderate problems;Severe problems;Extreme problems / Unable to. |
| Stroke or TIA (Transient ischemic attack) | 3, 12, 24 and 36 months | Incidence rate |
| All-cause death | after 3, 12, 24 and 36 months | Incidence rate; cardiovascular or non-cardiovascular |
Countries
Switzerland
Contacts
CONTACTPatrick Badertscher, PD Dr. med.
PRINCIPAL_INVESTIGATORPatrick Badertscher, PD Dr. med.
University Hospital, Basel, Switzerland
Outcome results
None listed