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

简要总结

详细描述

盲法说明

主要结局

次要结局

• Treatment-emergent adverse events: Cardiac tamponade requiring drainage(Day 0-90 post-ablation)
• Treatment-emergent adverse events: Persistent phrenic nerve palsy lasting >24 hours(Day 0-90 post-ablation)
• Treatment-emergent adverse events: Serious vascular complication requiring intervention(Day 0-90 post-ablation)
• Treatment-emergent adverse events: Stroke or TIA(Day 0-90 post-ablation)
• Treatment-emergent adverse events: Atrioesophageal fistula(Day 0-90 post-ablation)
• Treatment-emergent adverse events: Death(Day 0-90 post-ablation)
• Total procedure time(Day 0, during procedure)
• Total left atrial indwelling time(Day 0, during procedure)
• Total fluoroscopy time(Day 0, during procedure)
• Total radiation dose(Day 0, during procedure)
• 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)
• Post-ablation 3D-EAM: Assessment of atrial low-voltage/scar(Day 0, shortly after ablation)
• Post-ablation 3D-EAM: Proportion of isolated veins(Day 0, shortly after ablation)
• Post-ablation 3D-EAM: Proportion of isolated carinas(Day 0, shortly after ablation)
• Post-ablation 3D-EAM: Lesion size(Day 0, shortly after ablation)
• Post-ablation 3D-EAM: Posterior wall ablation success rate(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(up to 3 years)
• Arrhythmia burden for each participant between days 0-60 evaluated based on continuous ICM (Implantable cardiac monitor)(Day 0-60 post-ablation)
• Arrhythmia burden for each participant between days 61 and 365 evaluated based on continuous ICM(Day 61-365 post-ablation)
• 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))
• Correlation of AF burden to symptoms and quality of life (QoL) changes(Day 0-365 post-ablation)
• Reduction of AF burden by > 90% post ablation procedure(up to 3 years)
• 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)
• 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)
• Prevalence of persistent or paroxysmal atrial fibrillation(up to 3 years)
• Average heart rate(Months 1, 2 and 3 post-ablation)
• Hospital or emergency room admission due to documented recurrence of atrial arrhythmias(up to 3 years)
• Repeat ablation procedure due to documented recurrence of atrial arrhythmias(up to 3 years)
• Reinitiation or continuation of antiarrhythmic drug therapy(up to 3 years)
• Electrical cardioversion due to recurrence(up to 3 years)
• Number of reconnected veins evaluated during redo procedures(During redo procedures between day 1 to 36 months post-ablation)
• Number of reconnected posterior walls evaluated during redo procedures(During redo procedures between day 1 to 36 months post-ablation)
• Evolution of QoL(Day 90 and day 365 post-ablation)
• Stroke or TIA (Transient ischemic attack)(3, 12, 24 and 36 months)
• All-cause death(after 3, 12, 24 and 36 months)