Posterior mitral line with Vein of Marshall ethanolization vs anterior mitral lines for persistent atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares two catheter ablation strategies for persistent atrial fibrillation: a posterior mitral isthmus line with Vein of Marshall ethanol infusion versus an anterior mitral line. All participants will have prior pulmonary vein isolation and then undergo the chosen mitral isthmus ablation during standard care, with follow-up at 1, 3, and 6 months including ECGs, echocardiography, blood tests, Holter monitoring, and CT imaging. The primary aim is to determine which approach provides superior rhythm control and safety. The study enriches understanding of how to optimize left atrial ablation strategies in persistent AF and whether the Vein of Marshall–ethanol approach adds value.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.
* 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.

Where it's running

• AZ Sint-Jan Brugge AV
  Bruges, Belgium Recruiting

Study contacts

• Principal investigator: Sébastien Knecht, MD, PhD — AZ Sint-Jan Brugge AV
• Study coordinator: Emma Christiaen, PhD
• Email: emma.christiaen@azsintjan.be
• Phone: 003250453293

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.