Clinical Trial

Added Value of Vein of Marshal Ethanol Infusion Compared to Superior Vena Cava Isolation Alone in Patients Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation Despite Durable PV Isolation

Study acronym: VEIN-AF
Recruiting
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Summary
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
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2020-08-24; most recent amendment 2026-05-07.
Status change: Not Yet Recruiting → Recruiting 2020-09-22
Trial Details
NCT Number NCT04529785
Lead Sponsor AZ Sint-Jan AV
Conditions Paroxysmal Atrial Fibrillation
Enrollment 100 participants
Start Date 2020-09-11
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-12