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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
206
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 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
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
Time to first recurrence of any atrial tachyarrhythmia day 91-365
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
Time frame: Day 91-365 post-ablation
Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 91-365 evaluated based on continuous ICM
Key secondary efficacy endpoint
Time frame: Day 91-365 post-ablation
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
Treatment-emergent adverse events: Death
Number of patients with fatal outcome/death after PVI
Time frame: Day 0-90 post-ablation
Time to first recurrence of any atrial tachyarrhythmia day 0-365
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
Time frame: Day 0-365 post-ablation
Time to first recurrence of any atrial tachyarrhythmia day 0-90
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
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 electro-anatomical mapping: Proportion of isolated veins
Procedural endpoint
Time frame: Day 0, shortly after ablation
Post-ablation 3D electro-anatomical mapping: Posterior wall ablation success rate
Procedural endpoint; experimental group only
Time frame: Day 0, shortly after ablation
Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 0-90 evaluated based on continuous ICM
Secondary endpoint during follow-up
Time frame: Day 0-90 post-ablation
Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 0-365 evaluated based on continuous ICM
Secondary endpoint during follow-up
Time frame: Day 0-365 post-ablation
Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 365 until explantation or end of life (EOL) of the ICM
Secondary endpoint during follow-up
Time frame: 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 changes
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
Time frame: Day 0-365 post-ablation
Time to first recurrence of atrial flutter/ atrial tachycardia day 91-365
Secondary endpoint during follow-up
Time frame: Day 91-365 post-ablation
Time to first recurrence of atrial flutter/ atrial tachycardia day 0-90
Secondary endpoint during follow-up
Time frame: Day 0-90 post-ablation
Time to first recurrence of atrial flutter/ atrial tachycardia day 0-365
Secondary endpoint during follow-up
Time frame: Day 0-365 post-ablation
Time to first recurrence of persistent or paroxysmal atrial fibrillation day 91-365
Secondary endpoint during follow-up
Time frame: Day 91-365 post-ablation
Time to first recurrence of persistent or paroxysmal atrial fibrillation day 0-90
Secondary endpoint during follow-up
Time frame: Day 0-90 post-ablation
Time to first recurrence of persistent or paroxysmal atrial fibrillation day 0-365
Secondary endpoint during follow-up
Time frame: Day 0-365 post-ablation
Average heart rate as recorded by the ICM in months 1, 2 and 3 after ablation
Secondary endpoint during follow-up
Time frame: Months 1, 2 and 3 post-ablation
Hospital or emergency room admission due to atrial arrhythmia recurrence
Incidence rate
Time frame: Day 0-365 post-ablation
Repeat ablation due to recurrence of atrial arrhythmias
Incidence rate
Time frame: Day 0-365 post-ablation
Electrical cardioversion due to recurrence
Incidence rate
Time frame: Day 0-365 post-ablation
Reinitiation or continuation of antiarrhythmic drug therapy day 91-365
Incidence rate
Time frame: Day 0-365 post-ablation
Number of reconnected pulmonary veins evaluated during redo procedures
Secondary endpoint during follow-up
Time frame: During redo procedures between day 1 to 36 months post-ablation
Sites of reconnection (anterior, posterior, superior, inferior) of the pulmonary veins evaluated during redo procedures
Secondary endpoint during follow-up
Time frame: During redo procedures between day 1 to 36 months post-ablation
Size of antral scar area (cm²) of the pulmonary veins evaluated during redo procedures
Secondary endpoint during follow-up
Time frame: During redo procedures between day 1 to 36 months post-ablation
Number of reconnected posterior walls evaluated during redo procedures
Secondary endpoint during follow-up
Time frame: During redo procedures between day 1 to 36 months post-ablation
Sites of reconnection of the posterior wall evaluated during redo procedures
Secondary endpoint during follow-up
Time frame: During redo procedures between day 1 to 36 months post-ablation
Size of the scar area (cm²) of the posterior wall evaluated during redo procedures
Secondary endpoint during follow-up
Time frame: During redo procedures between day 1 to 36 months post-ablation
EQ-5D-5L Composite score month 3
Quality of life wil be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes. Composite score month 3.
Time frame: Day 90 post-ablation
EQ-5D-5L Composite score month 12
Quality of life wil be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes. Composite score month 12.
Time frame: Day 365 post-ablation
EQ-5D-5L Visual analogue scale month 3
Quality of life wil be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes. Visual analogue scale month 3.
Time frame: Day 90 post-ablation
EQ-5D-5L Visual analogue scale month 12
Quality of life wil be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes. Visual analogue scale month 12.
Time frame: Day 365 post-ablation
AFEQT month 3
Quality of life wil be measured with the AFEQT questionnaire.
Time frame: Day 90 post-ablation
AFEQT month 12
Quality of life wil be measured with the AFEQT questionnaire.
Time frame: Day 365 post-ablation
Stroke or transient ischemic attack day 0-365
Incidence rate
Time frame: Day 0-365 post-ablation
All-cause death day 0-365
Incidence rate
Time frame: Day 0-365 post-ablation
Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥1 hour
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
Time frame: Day 91-365 post-ablation
Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥6 hour
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
Time frame: Day 91-365 post-ablation
Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥1 day
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
Time frame: Day 91-365 post-ablation
Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥2 days
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
Time frame: Day 91-365 post-ablation
Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥7 days
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
Time frame: Day 91-365 post-ablation
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