About this trial
The superior vena cava (SVC) is one of the most common non pulmonary vein (PV)-triggers for atrial tachyarrhythmias. SVC electrical isolation can be reached by circular radiofrequency (RF)-ablation under close monitoring of the phrenic nerve. However, adding substrate modification and vein of Marshal (VoM) ethanol infusion to the ablation procedure might substantially improve long-term outcomes.
The aim of this study is to evaluate the recurrence rate 1 year after the index ablation in patients undergoing a redo ablation for recurrent paroxysmal atrial fibrillation (PAF) despite durable pulmonary vein isolation (PVI) with either SVC isolation alone or with substrate modification including vein of Marshal ethanolisation in addition to SVC isolation alone
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients older than 18 years
Patients scheduled for a repeat ablation of PAF after a previous PVI
Confirmation of lasting pulmonary vein isolation at the time of randomization
Disqualifiers
Patients with persistent atrial fibrillation
Previous ablation with isolation of the SVC, roofline, mitral line or previous vein of Marshal ethanol infusion
Left atrial thrombus. Left atrial appendage thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI.
Left ventricular ejection fraction <35%.
Trial design
Parallel
Treatments tested in this trial
SVC only
Procedure/SurgeryPatients allocated to this arm will receive an RF ablation with the isolation of the SVC alone
SVC isolation with substrate modification and vein of Marshal ethanol infusion
Procedure/SurgeryPatients allocated to this arm will receive an RF ablation with the isolation of the SVC, substrate modification and vein of Marshal ethanol infusion
Treatment groups
Trial outcomes
Primary outcomes
Recurrence of atrial tachyarrhythmia 1 year after the index ablation
Comparison of the prevalence of atrial tachyarrhythmia recurrence 1 year after the index ablation between groups
Safety (complications)
Comparison of the number of procedural complications between groups
Secondary outcomes
Total procedural time
Comparison of the procedural time between groups
Fluoroscopy time
Comparison of the fluoroscopy time between groups
RF ablation time
Comparison of the radiofrequency time between groups
Sponsors and contacts
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