NCT04529785

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

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 Pulmonary Vein Isolation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: AZ Sint-Jan AV · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	SVC only	Patients allocated to this arm will receive an RF ablation with the isolation of the SVC alone
PROCEDURE	SVC isolation with substrate modification and vein of Marshal ethanol infusion	Patients allocated to this arm will receive an RF ablation with the isolation of the SVC, substrate modification and vein of Marshal ethanol infusion

Timeline

• Start date: 2020-09-11
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2020-08-28
• Last updated: 2022-08-03

Locations

1 site across 1 country: Belgium