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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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

Eligibility

Primary outcome measure(s)

• Number of patients with procedural linear bidirectional block — During procedure
  After first-pass ablation, bidirectional block across the mitral isthmus line will be assessed by conventional methods consisting of differential pacing maneuvers and documenting widely separated double potentials across the entire length of the line and high-density activation mapping with the Optrell catheter. In the case of absence of block, PF applications will be carried out on the RF line where the earliest activation will be evidenced, for an target index of \>550. In the case of absence of block after PF ablation, additional RF and PF ablation points will be performed at the earliest activation sites, adjacent to the previous lesions. A maximum total duration of RF and PF application of 20 min will be allowed for both lines, after which the failure of block will be accepted. Bidirectional conduction block will be reassessed ≥10min after the last ablation lesion along the lines.

Trial sites (1)

More AZ Sint-Jan AV trials in Belgium

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