Status:
NOT_YET_RECRUITING
Posterior Mitral Isthmus Line With Vein of Marshall Ethanolisation Compared With Anterior Mitral Lines in Patients With Persistent Atrial Fibrillation
Lead Sponsor:
AZ Sint-Jan AV
Conditions:
Persistent Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
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 a...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT06962176
Start Date
July 1 2025
End Date
July 1 2027
Last Update
May 8 2025
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