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Posterior Mitral Isthmus Line With Vein of Marshall Ethanolisation Compared With Anterior Mitral Lines in Patients With Persistent Atrial Fibrillation

NCT06962176 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-05-08

No results posted yet for this study

Summary

The goal of this clinical study is to find out which treatment works best for people with persistent atrial fibrillation (a type of irregular heartbeat). Researchers are comparing two types of heart ablation procedures:

* An anterior mitral line ablation (a treatment at the front part of the heart)
* A posterior mitral line ablation (at the back of the heart), sometimes with an extra step using a small vein called the Vein of Marshall

The main questions the study aims to answer are:

* Which approach works better at fixing the heart rhythm?
* Which approach is safer (less complications)?

People who take part in this study will:

* Undergo an ablation procedure as part of their standard care
* Attend follow-up visits at 1, 3, and 6 months
* Have tests like ECGs, heart ultrasound (echocardiogram), blood tests, heart rhythm monitors (Holter), and a heart CT scan

Conditions

  • Persistent Atrial Fibrillation

Interventions

PROCEDURE

Anterior Mitral Line Ablation

First pulmonary vein isolation (PVI) is performed - either as a first-time isolation (index procedure) or a re-isolation (in repeat procedures). Then a linear lesion is created on the anterior wall of the left atrium, from the roof line to the mitral annulus.

PROCEDURE

Posterior Mitral Isthmus Ablation with Vein of Marshall Ethanol Infusion

Pulmonary vein isolation (PVI) is systematically carried out before any additional ablation lines are created - either as initial isolation or re-isolation. In this group the posterior mitral isthmus, a region between the left inferior pulmonary vein and the mitral annulus, is targeted. Endocardial ablation using a dual energy catheter (RF and PF) is combined with ethanol infusion in the vein of Marshall (VOM), which ablates the adjacent epicardial tissue to enhance lesion durability.

Sponsors & Collaborators

  • AZ Sint-Jan AV

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2027-01-31
Completion
2027-07-31

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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 NCT06962176 on ClinicalTrials.gov