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

Launched by AZ SINT-JAN AV · Apr 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the best way to treat persistent atrial fibrillation, which is a condition where the heart beats irregularly. Researchers want to compare two different heart procedures: one that targets the front part of the heart (anterior mitral line ablation) and another that focuses on the back part (posterior mitral line ablation), with a special technique that uses a small vein called the Vein of Marshall. The main goals are to see which method is more effective in restoring a normal heart rhythm and which one has fewer complications.

To participate in this study, individuals must be between 18 and 80 years old and have symptoms related to persistent atrial fibrillation, with a need for a specific heart procedure. Participants will undergo the ablation procedure and will have follow-up visits at 1, 3, and 6 months after treatment. During these visits, they will have tests like heart ultrasounds and rhythm monitors to track their heart's health. It's important to note that certain health conditions, such as recent heart surgery or serious medical problems, may prevent someone from joining the trial.

Gender

ALL

Eligibility criteria

• 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.