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 (VEIN-AF)

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

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

Study Overview

• Status: Recruiting
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Procedure: SVC only; Procedure: SVC isolation with substrate modification and vein of Marshal ethanol infusion

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Lycke, MSc, PhD; Phone Number: +32 50 45 32 93; Email: michelle.lycke@azsintjan.be

Study Locations

• Belgium
  • Please Select
    • Bruges, Please Select, Belgium, 8000
      • Recruiting
      • AZ Sint-Jan Brugge-Oostende AV
      • Contact: Michelle Lycke, MSc, PhD; Phone Number: 00 32 45 32 93; Email: michelle.lycke@azsintjan.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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%.
• Cardiac surgery within the previous 90 days.
• Expecting cardiac transplantation or other cardiac surgery within 180 days.
• Coronary percutaneous transluminal coronary angioplasty/stenting within the previous 90 days or myocardial infarction within the previous 60 days.
• Documented history of a thromboembolic event within the previous 90 days.
• Diagnosed atrial myxoma.
• Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
• Women who are pregnant or who plan to become pregnant during the study.
• Acute illness or active infection at time of index procedure
• Advanced renal insufficiency
• Unstable angina.
• History of blood clotting or bleeding abnormalities.
• Contraindication to anticoagulation.
• Life expectancy less than 1 year.
• Presence of a condition that precludes vascular access.
• International Normalized Ratio greater than 3.5 within 24 hours of procedure - for patients taking warfarin.
• Patient cannot be removed from antiarrhythmic drugs for reasons other than AF.
• Unwilling or unable to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SVC only; Patients in Group 1 will receive an SVC isolation only	Procedure: SVC only; Patients allocated to this arm will receive an RF ablation with the isolation of the SVC alone
Active Comparator: SVC isolation with substrate modification and VoM inf; Patients in Group 2 will receive an SVC isolation with substrate modification and vein of Marshal ethanol infusion	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
Safety (complications)	Comparison of the number of procedural complications between groups	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total procedural time	Comparison of the procedural time between groups	During procedure
Fluoroscopy time	Comparison of the fluoroscopy time between groups	During procedure
RF ablation time	Comparison of the radiofrequency time between groups	During procedure

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Principal Investigator: Sébastien Knecht, MD, PhD, AZ Sint-Jan AV

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: 2700

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No