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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAZ Sint-Jan AV

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients between the ages of 18 and 80 years, diagnosed with symptomatic persistent AF with clinical indication for left atrial ablation with a mitral isthmus line. Pulmonary vein will be isolated in all patients before starting the mitral isthmus line (during a previous or the same procedure)

Disqualifiers

Previous mitral line or any other left atrial ablation beyond pulmonary vein isolation

Left atrial (LA) thrombus. LA thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI.

LA diameter greater than 60 mm on long axis parasternal view, or left atrial volume more than 250 cc.

Left ventricular ejection fraction <25%.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anterior Mitral Line Ablation

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: Anterior Mitral Line AblationExperimental treatment 1 intervention
Group B: Posterior Mitral Isthmus Ablation with Vein of Marshall Ethanol InfusionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with procedural linear bidirectional block

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.

Time frame
During procedure

Secondary outcomes

1

Procedural safety

Characterization of complications, including pericardial effusion, stroke and coronary stenosis

Time frame
6 months
2

Procedural parameters: total procedure time (min)

Comparison of procedural parameters between groups: total procedure time (min)

Time frame
During procedure
3

Procedural parameters: fluoroscopy time (min)

Comparison of procedural parameters between groups: fluoroscopy time (min)

Time frame
During procedure
4

Procedural parameters: total RF ablation time (min)

Comparison of procedural parameters between groups: total RF ablation time

Time frame
During procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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