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Persistent Atrial FibrillationMIVANTNCT06962176

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

A study testing Anterior Mitral Line Ablation and Posterior Mitral Isthmus Ablation with Vein of Marshall Ethanol Infusion in people with Persistent Atrial Fibrillation, run by AZ Sint-Jan AV at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Persistent Atrial Fibrillation
What is being tested?
Anterior Mitral Line Ablation and Posterior Mitral Isthmus Ablation with Vein of Marshall Ethanol Infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
1 siteBelgium
Study dates
24 Sep 2026to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.
  • History of blood clotting or bleeding abnormalities.
  • Contraindication to anticoagulation.
  • Life expectancy less than 1 year.
  • Uncontrolled heart failure.
  • Presence of a condition that precludes vascular access.
  • International normalised ratio (INR) greater than 4 within 24 hours of procedure - for patients taking warfarin.
  • Unwilling or unable to provide informed consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emma Christiaen, PhD contact

003250453293

emma.christiaen@azsintjan.be

Belgium1 site, 1 recruiting
  • AZ Sint-Jan Brugge AV

    Bruges, 8000

    Recruiting

Other trials in Belgium

About this study

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
Read more

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
Read the detailed description

The MIVANT trial aims to compare two different strategies for treating patients with persistent atrial fibrillation (AF) using catheter ablation techniques. AF is a common heart rhythm disorder, and in persistent forms, it often does not respond adequately to pulmonary vein isolation (PVI) alone. For this reason, many patients require additional ablation lines in the left atrium to reduce arrhythmia recurrence and improve long-term rhythm control.

One such ablation strategy involves creating a linear lesion across the mitral isthmus-a region between the mitral valve and the pulmonary veins. There are two main anatomical approaches to target this area:

  • The anterior mitral line, which connects the right superior pulmonary vein to the mitral annulus
  • The posterior mitral line, which connects the left inferior pulmonary vein to the mitral annulus

The posterior line is technically more challenging because of the complex anatomy, proximity to blood vessels, and epicardial electrical pathways that can bypass endocardial lesions. However, this difficulty can be addressed by a technique known as Vein of Marshall (VOM) ethanol infusion. The VOM is a small vein near the mitral isthmus that contains nerve fibers and muscle bundles involved in atrial arrhythmias. Infusing ethanol into this vein can help create more effective and lasting ablation lines by reaching areas that standard catheter ablation cannot.

The MIVANT study will enroll 146 adult patients with persistent atrial fibrillation who are already scheduled to receive additional ablation beyond PVI. Patients will be randomized in a 1:1 ratio to undergo either:

  • A posterior mitral line ablation, with or without ethanol infusion into the Vein of Marshall, depending on anatomical feasibility
  • An anterior mitral line ablation without ethanol infusion

All procedures will be performed under general anesthesia or conscious sedation, using state-of-the-art mapping and ablation tools. Standardized ablation parameters will be followed to ensure consistency and quality across sites.

The main objective of this study is to determine whether the posterior approach-with possible VOM infusion-leads to a higher success rate of procedural bidirectional block across the mitral line, compared to the anterior approach.

Secondary objectives include assessing:

  • Safety outcomes such as bleeding, stroke, or coronary artery injury
  • Efficiency of the procedure, including total time, fluoroscopy exposure, and number of lesions needed
  • Recurrence of atrial arrhythmias at 6 months
  • Patient quality of life
  • Hospitalizations related to cardiovascular events

Participants will attend follow-up visits at 1, 3, and 6 months, during which they will undergo tests such as ECGs, echocardiography, Holter monitoring, CT coronary angiography, and blood tests.

This study is expected to last a total of 24 months, with 18 months allocated for patient recruitment and a minimum of 6 months follow-up per participant. The study is coordinated by AZ Sint-Jan Brugge AV in Belgium, with possible collaboration from other high-volume centers in France and Switzerland.

The findings of the MIVANT study will help clarify whether posterior mitral isthmus ablation-with the aid of Vein of Marshall ethanolisation-is a more effective and equally safe alternative to the anterior approach in the treatment of persistent atrial fibrillation.

Being tested
Anterior Mitral Line Ablation, Posterior Mitral Isthmus Ablation with Vein of Marshall Ethanol Infusion
Keywords
Persistent Atrial Fibrillation, Catheter ablation, Vein of Marshall ethanolization, Mitral line ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anterior Mitral Line AblationProcedure or 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 InfusionProcedure or 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.

Study groups in NCT06962176
Study groupRoleWhat they receive
Anterior Mitral Line AblationExperimentalFirst 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.
Receives: Procedure: Anterior Mitral Line Ablation
Posterior Mitral Isthmus Ablation with Vein of Marshall Ethanol InfusionExperimentalAs 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.
Receives: Procedure: Posterior Mitral Isthmus Ablation with Vein of Marshall Ethanol Infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: During procedure

Secondary outcomes (10)
  1. Procedural safety

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

    Measured: 6 months

  2. Procedural parameters: total procedure time (min)

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

    Measured: During procedure

  3. Procedural parameters: fluoroscopy time (min)

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

    Measured: During procedure

  4. Procedural parameters: total RF ablation time (min)

    Comparison of procedural parameters between groups: total RF ablation time

    Measured: During procedure

  5. Procedural parameters: total ablation time (min)

    Comparison of procedural parameters between groups: total ablation time

    Measured: During procedure

  6. Procedural parameters: number of ablation lesions required

    Comparison of procedural parameters between groups: number of ablation lesions required

    Measured: During procedure

  7. Cardiovascular-related hospitalizations

    Characterization of cardiovascular-related hospitalizations in both groups

    Measured: 6 months

  8. Recurrence of arrhythmia

    Recurrence of arrhythmia, assessed 24 hour Holter monitoring 3 months post procedure and 7-day Holter monitoring 6 months post procedure

    Measured: 6 months

  9. Quality of life (SF-36 and AF Symtoms Checklist)

    Characterization of quality of life, assessed using the 36-Item Short Form Survey Instrument (SF-36) and the AF Symptom Checklist

    Measured: 6 months

  10. Left atrial function at 6 months follow-up

    Left atrial function at 6 months follow-up, assessed using transthoracic echocardiography

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2025
  2. Study start24 Sep 2026
  3. Primary completionJan 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
146 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06962176
Sponsor's protocol ID
MIVANT
Acronym
MIVANT
Status last verified
Oct 2026
First submitted
22 Apr 2025
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Anterior Mitral Line Ablation and Posterior Mitral Isthmus Ablation with Vein of Marshall Ethanol Infusion in people with Persistent Atrial Fibrillation, run by AZ Sint-Jan AV at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emma Christiaen, PhD (003250453293, emma.christiaen@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with procedural linear bidirectional block (time frame: During procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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