[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Imricor Medical Systems\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":20,"type":21},91,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Atrial Flutter Typical",[29,30],"RF Ablation","interventional Cardiac Magnetic Resonance (iCMR)","RECRUITING","2026-04-08",{"date":34,"type":35},"2026-04-13","ACTUAL",{"date":37,"type":35},"2024-06-20",{"date":39,"type":21},"2026-12-31",{"name":41,"class":42},"Imricor Medical Systems","INDUSTRY",6,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100481038","vt-ablation-in-the-icmr-100481038","NCT05543798","VT Ablation in the iCMR","Vision-MR Ablation Catheter 2.0 for the Treatment of Ventricular Tachycardia","VISABL-VT","Inclusion Criteria:\n\n* Roll-in subjects only: Documentation of premature ventricular contractions indicated for ablation therapy (subjects may or may not be diagnosed with Ischemic Cardiomyopathy)\n* Documented (ECG\u002FEGM) spontaneous episode of sustained ventricular tachycardia within 6 months of the procedure\n* Diagnosis of Ischemic Cardiomyopathy\n* AAD therapy refractory, contraindicated, not tolerated, or not desired\n* 18 years or older\n\nExclusion Criteria:\n\n* Implanted with non-MR compatible medical devices or contraindicated for an MRI\n* Presence of intracardiac thrombus (verified via CT\u002FMRI\u002FTEE\u002FTTE within 48 hours of procedure - or at start of procedure)\n* Thrombocytopenia or coagulopathy\n* Mechanical mitral and\u002For aortic valve precluding access to the left ventricle\n* Severe aortic stenosis\n* Myocardial infarction requiring stent implantation within 90 days of procedure\n* Previous cardiac surgery within 60 days of procedures\n* Known\u002Funcontrolled stroke risks\n* Class IV Heart Failure\n* Ejection Fraction (EF) \\\u003C 25%\n* Patients with a glomerular filtration rate (GFR) \\\u003C 30\n* Women who are pregnant\n* Allergy to contrast agents (e.g., Gadolinium)\n* Active infection\n* Known or suspected myxoma\n* Unstable angina\n* Patients who do not tolerate anticoagulation therapy\n* Previous intertribal septal patch or prosthetic atrial septal defect closure device\n* Life expectancy \\\u003C 12 months\n* Enrollment in another study without sponsor approval",{"count":53,"type":21},64,[24],"The VISABL-VT is a prospective, single-arm, multi-center, interventional investigation of the safety and efficacy of radiofrequency (RF) ablation of ventricular tachycardia associated with ischemic cardiomyopathy performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.",[57],"Ventricular Tachycardia","2026-01-06",{"date":60,"type":35},"2026-01-08",{"date":62,"type":35},"2025-04-10",{"date":64,"type":21},"2027-06",{"name":41,"class":42},3,""]