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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

NCT04529785 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • AZ Sint-Jan AV

    lead OTHER

Principal Investigators

  • Sébastien Knecht, MD, PhD · AZ Sint-Jan AV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-11
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04529785 on ClinicalTrials.gov