[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590035":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":23,"responsibleParty":38,"collaborators":23,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":23,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":64,"whyStopped":23,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":23},{"fullName":5,"class":6},"AZ Sint-Jan AV","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Anterior Mitral Line Ablation","EXPERIMENTAL","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.",[13],"Procedure: Anterior Mitral Line Ablation",{"label":15,"type":10,"description":16,"interventionNames":17},"Posterior Mitral Isthmus Ablation with Vein of Marshall Ethanol Infusion","As 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.",[18],"Procedure: Posterior Mitral Isthmus Ablation with Vein of Marshall Ethanol Infusion",[20,24],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":23},"PROCEDURE",[9],null,{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":23},"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.",[15],[28],{"name":29,"affiliation":30,"role":31},"Sébastien Knecht, MD, PhD","AZ Sint-Jan Brugge AV","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":23,"email":37},"Emma Christiaen, PhD","CONTACT","003250453293","emma.christiaen@azsintjan.be",{"type":31,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Sebastien Knecht","Coordinating investigator","100590035","posterior-mitral-isthmus-line-with-vein-of-marshall-ethanolisation-compared-with-anterior-mitral-lines-in-patients-with-persistent-atrial-fibrillation-100590035",false,"NCT06962176","Posterior Mitral Isthmus Line With Vein of Marshall Ethanolisation Compared With Anterior Mitral Lines in Patients With Persistent Atrial Fibrillation","MIVANT","Inclusion Criteria:\n\n* 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)\n\nExclusion Criteria:\n\n* Previous mitral line or any other left atrial ablation beyond pulmonary vein isolation\n* Left atrial (LA) thrombus. LA thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI.\n* LA diameter greater than 60 mm on long axis parasternal view, or left atrial volume more than 250 cc.\n* Left ventricular ejection fraction \\\u003C25%.\n* Cardiac surgery within the previous 90 days.\n* Expecting cardiac transplantation or other cardiac surgery within 180 days.\n* Percutaneous transluminal coronary angioplasty\u002Fstenting or myocardial infarction within the previous 30 days.\n* Documented history of a thromboembolic event within the previous 60 days.\n* Diagnosed atrial myxoma.\n* Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.\n* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment\n* Women who are pregnant or who plan to become pregnant during the study.\n* Acute illness or active infection at time of index procedure\n* Renal insufficiency\n* Unstable angina.\n* History of blood clotting or bleeding abnormalities.\n* Contraindication to anticoagulation.\n* Life expectancy less than 1 year.\n* Uncontrolled heart failure.\n* Presence of a condition that precludes vascular access.\n* International normalised ratio (INR) greater than 4 within 24 hours of procedure - for patients taking warfarin.\n* Unwilling or unable to provide informed consent.","ALL","18 Years","80 Years",{"count":52,"type":53},146,"ESTIMATED","INTERVENTIONAL",[56],"NA","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:\n\n* An anterior mitral line ablation (a treatment at the front part of the heart)\n* 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\n\nThe main questions the study aims to answer are:\n\n* Which approach works better at fixing the heart rhythm?\n* Which approach is safer (less complications)?\n\nPeople who take part in this study will:\n\n* Undergo an ablation procedure as part of their standard care\n* Attend follow-up visits at 1, 3, and 6 months\n* Have tests like ECGs, heart ultrasound (echocardiogram), blood tests, heart rhythm monitors (Holter), and a heart CT scan",[59],"Persistent Atrial Fibrillation",[59,61,62,63],"Catheter ablation","Vein of Marshall ethanolization","Mitral line ablation","NOT_YET_RECRUITING","2025-04-29",{"date":67,"type":68},"2025-05-08","ACTUAL",{"date":70,"type":53},"2025-07",{"date":72,"type":53},"2027-07",{"name":5,"class":6}]