[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508755":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":120,"collaborators":20,"id":122,"slug":20,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":123,"sex":129,"minAge":130,"maxAge":20,"enrollmentInfo":131,"targetDuration":20,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Imricor Medical Systems","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Vision-MR Atrial Flutter Ablation","EXPERIMENTAL","Type 1 Atrial Flutter ablation performed in the iCMR with the Vision-MR Ablation Catheter 2.0 and associated Advantage-MR EP recorder and stimulator system.",[13],"Device: RF Ablation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","RF Ablation","RF ablation for type I atrial flutter under iCMR guidance",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Kate Lindborg","Imricor Medical Systems, Inc.","STUDY_DIRECTOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","952-818-8400","kate.lindborg@imricor.com",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Jennifer Somerville","952-594-4138","jennifer.somerville@imricor.com",[36,53,67,82,95,107],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Johns Hopkins University (JHU)","RECRUITING","Baltimore","Maryland","21218","United States",{"type":44,"coordinates":45},"Point",[46,47],-76.61219,39.29038,{"lat":47,"lon":46},[50],{"name":51,"role":52,"phone":20,"phoneExt":20,"email":20},"Aravindan Kolandaivelu, MD","PRINCIPAL_INVESTIGATOR",{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":42,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"University of Virginia (UVA)","NOT_YET_RECRUITING","Charlottesville","Virginia","22903",{"type":44,"coordinates":60},[61,62],-78.47668,38.02931,{"lat":62,"lon":61},[65],{"name":66,"role":52,"phone":20,"phoneExt":20,"email":20},"Kenneth Bilchick, MD",{"facility":68,"status":55,"city":69,"state":57,"zip":70,"country":42,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Virginia Commonwealth University","Richmond","23284",{"type":44,"coordinates":72},[73,74],-77.46026,37.55376,{"lat":74,"lon":73},[77,81],{"name":78,"role":28,"phone":79,"phoneExt":20,"email":80},"Ajay Pillai, M.D.","478-957-2109","ajay.pillai@vcuhealth.org",{"name":78,"role":52,"phone":20,"phoneExt":20,"email":20},{"facility":83,"status":38,"city":84,"state":20,"zip":85,"country":86,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"l'institut Cardiologique Paris Sud (ICPS)","Massy","91300","France",{"type":44,"coordinates":88},[89,90],2.28301,48.72692,{"lat":90,"lon":89},[93],{"name":94,"role":52,"phone":20,"phoneExt":20,"email":20},"Laurent Fiorina, MD",{"facility":96,"status":38,"city":97,"state":20,"zip":20,"country":98,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Amsterdam University Medical Center (AUMC)","Amsterdam","Netherlands",{"type":44,"coordinates":100},[101,102],4.88969,52.37403,{"lat":102,"lon":101},[105],{"name":106,"role":52,"phone":20,"phoneExt":20,"email":20},"Michiel J.B. Kemme, MD",{"facility":108,"status":38,"city":109,"state":20,"zip":110,"country":111,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"University Hospital of Vaud (CHUV)","Lausanne","1011","Switzerland",{"type":44,"coordinates":113},[114,115],6.63282,46.516,{"lat":115,"lon":114},[118],{"name":119,"role":52,"phone":20,"phoneExt":20,"email":20},"Juerg Schwitter, MD",{"type":121,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100508755",false,"NCT05904548","Atrial Flutter Ablation in the iCMR","Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter","VISABL-AFL","Inclusion Criteria:\n\n* Patient indicated for type I atrial flutter ablations with at least 1 documented episode of type I atrial flutter within 6 months (180 days) of enrollment\n* Patient 18 years and older\n\nExclusion Criteria:\n\n* Contraindications for MRI procedures\n* Patients who cannot have anti-arrhythmic drugs (class I or class III) prescribed for the treatment of type I atrial flutter stopped on the day of the procedure\n* Previous CTI ablation procedures\n* Myocardial infarction within 60 days of enrollment\n* Current unstable angina\n* Cardiac surgery within 90 days of enrollment\n* Any cerebral ischemic event (including transient ischemic attacks) within 6 months (180 days) of enrollment\n* Thrombocytosis or thrombocytopenia\n* Contraindication to anticoagulation therapy\n* Currently documented intracardiac thrombus or myxoma\n* Implantation of permanent leads of an implantable device in or through the right atrium within 90 days of enrollment\n* Prosthetic valve through which the catheter must pass\n* Interatrial baffle or patch through which the catheter must pass\n* Moderate or severe tricuspid valve regurgitation or stenosis\n* Uncompensated congestive heart failure\n* Active systemic infection\n* Pregnancy or if subject plans to become pregnant during the trial\n* Uncontrolled hyperthyroidism\n* Any other significant uncontrolled or unstable medical condition\n* Enrollment in any concurrent study without Imricor written approval\n* Life expectancy of less than or equal to 2 years (730 days) per physician opinion","ALL","18 Years",{"count":132,"type":133},91,"ESTIMATED","INTERVENTIONAL",[136],"NA","The VISABL-AFL clinical investigation is a prospective, single-arm, multi-center, interventional, Investigational Device Exemption (IDE) trial. The primary objectives of VISABL-AFL are to assess the safety and efficacy of radiofrequency (RF) ablation of type-I atrial flutter performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.",[139],"Atrial Flutter Typical",[17,141],"interventional Cardiac Magnetic Resonance (iCMR)","2026-04-08",{"date":144,"type":145},"2026-04-13","ACTUAL",{"date":147,"type":145},"2024-06-20",{"date":149,"type":133},"2026-12-31",{"name":5,"class":6},6]