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

RecruitingNAAges 18 Years - 80 YearsAllAZ Sint-Jan AV
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Anterior Mitral Line Ablation
  • Posterior Mitral Isthmus Ablation with Vein of Marshall Ethanol Infusion
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Where

1 site
AZ Sint-Jan Brugge AV
Bruges, Belgium
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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