[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508755":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":124,"collaborators":20,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":128,"sex":134,"minAge":135,"maxAge":20,"enrollmentInfo":136,"targetDuration":20,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"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",[36,54,68,83,97,110],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Johns Hopkins University (JHU)","RECRUITING","Baltimore","Maryland","21218","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-76.61219,39.29038,{"lat":48,"lon":47},[51],{"name":52,"role":53,"phone":20,"phoneExt":20,"email":20},"Aravindan Kolandaivelu, MD","PRINCIPAL_INVESTIGATOR",{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":42,"countryCode":43,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"University of Virginia (UVA)","NOT_YET_RECRUITING","Charlottesville","Virginia","22903",{"type":45,"coordinates":61},[62,63],-78.47668,38.02931,{"lat":63,"lon":62},[66],{"name":67,"role":53,"phone":20,"phoneExt":20,"email":20},"Kenneth Bilchick, MD",{"facility":69,"status":56,"city":70,"state":58,"zip":71,"country":42,"countryCode":43,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Virginia Commonwealth University","Richmond","23284",{"type":45,"coordinates":73},[74,75],-77.46026,37.55376,{"lat":75,"lon":74},[78,82],{"name":79,"role":28,"phone":80,"phoneExt":20,"email":81},"Ajay Pillai, M.D.","478-957-2109","ajay.pillai@vcuhealth.org",{"name":79,"role":53,"phone":20,"phoneExt":20,"email":20},{"facility":84,"status":38,"city":85,"state":20,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"l'institut Cardiologique Paris Sud (ICPS)","Massy","91300","France","FR",{"type":45,"coordinates":90},[91,92],2.28301,48.72692,{"lat":92,"lon":91},[95],{"name":96,"role":53,"phone":20,"phoneExt":20,"email":20},"Laurent Fiorina, MD",{"facility":98,"status":38,"city":99,"state":20,"zip":20,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Amsterdam University Medical Center (AUMC)","Amsterdam","Netherlands","NL",{"type":45,"coordinates":103},[104,105],4.88969,52.37403,{"lat":105,"lon":104},[108],{"name":109,"role":53,"phone":20,"phoneExt":20,"email":20},"Michiel J.B. Kemme, MD",{"facility":111,"status":38,"city":112,"state":20,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"University Hospital of Vaud (CHUV)","Lausanne","1011","Switzerland","CH",{"type":45,"coordinates":117},[118,119],6.63282,46.516,{"lat":119,"lon":118},[122],{"name":123,"role":53,"phone":20,"phoneExt":20,"email":20},"Juerg Schwitter, MD",{"type":125,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100508755","atrial-flutter-ablation-in-the-icmr-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":137,"type":138},91,"ESTIMATED","INTERVENTIONAL",[141],"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.",[144],"Atrial Flutter Typical",[17,146],"interventional Cardiac Magnetic Resonance (iCMR)","2026-04-08",{"date":149,"type":150},"2026-04-13","ACTUAL",{"date":152,"type":150},"2024-06-20",{"date":154,"type":138},"2026-12-31",{"name":5,"class":6},6]