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

NCT06962176 | Not Yet Recruiting

• 1 other identifier: MIVANT
• Study Type: interventional
• Target: 146
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Persistent Atrial Fibrillation; Catheter ablation; Vein of Marshall ethanolization; Mitral line ablation

Outcome Measures

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.

  During procedure

Secondary Outcomes (10)

• Procedural safety

  6 months

• Procedural parameters: total procedure time (min)

  During procedure

• Procedural parameters: fluoroscopy time (min)

  During procedure

• Procedural parameters: total RF ablation time (min)

  During procedure

• Procedural parameters: total ablation time (min)

  During procedure

Study Arms (2)

Anterior Mitral Line Ablation

EXPERIMENTAL

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: Anterior Mitral Line Ablation

Posterior Mitral Isthmus Ablation with Vein of Marshall Ethanol Infusion

EXPERIMENTAL

As with the anterior approach, 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.

Procedure: Posterior Mitral Isthmus Ablation with Vein of Marshall Ethanol Infusion

Interventions

Posterior Mitral Isthmus Ablation with Vein of Marshall Ethanol Infusion PROCEDURE

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.

Posterior Mitral Isthmus Ablation with Vein of Marshall Ethanol Infusion

Anterior Mitral Line Ablation PROCEDURE

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.

Anterior Mitral Line Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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%.
• Cardiac surgery within the previous 90 days.
• Expecting cardiac transplantation or other cardiac surgery within 180 days.
• Percutaneous transluminal coronary angioplasty/stenting or myocardial infarction within the previous 30 days.
• Documented history of a thromboembolic event within the previous 60 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
• Renal insufficiency
• Unstable angina.

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sébastien Knecht, MD, PhD

  AZ Sint-Jan Brugge AV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Christiaen, PhD

CONTACT

003250453293; emma.christiaen@azsintjan.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating investigator

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 8, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share