[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Stereotaxis\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100517615","the-magic-cardiac-ablation-european-study-100517615",false,"NCT06019845","The MAGiC™ Cardiac Ablation European Study","The MAGiC™ Cardiac Ablation Feasibility Study \u002F Pomt Market Clinical Follow-Up","MAGiC-FESTPMCF","Inclusion Criteria:\n\n* Adult (aged 18 or older at time of consent);\n* Eligible for ablation procedures of an atrial or ventricular arrhythmia per European Heart Rhythm Association (EHRA) guidelines, lctrocardiographically documented within 12 months \\[rior to enrollment;\n* Able to be safely exposed to magnetic fields;\n* Willing and capable to attend scheduled follow up visits at the study site for the study duration (up to 12 months)\n* Willing and able to provide informed consent.\n\nExclusion Criteria:\n\n* Unable to be safely exposed to magnetic fields due to Magnetic Resonance Imaging Unsafe device (implanted device or device that cannot be safely removed for the procedure)\n* Unable to remain comfortable or hemodynamically stable in the supine position for an extended period of time\n* Weight exceeding 200 kg (the weight limit of the table)\n* Women of childbearing age who are pregnant or who plan to become pregnant within the course of their participation in the study. Must have a negative pregnancy test.\n* Presence of intracardiac thrombus within 12 weeks prior to enrollment\n* Where MAGiC would need to cross a prosthetic valve\n* Use of MAGiC in the coronary arteries\n* A history of sensitivity to foreign objects or extreme allergies\n* Acute illness or active systemic infection\n* Histological or anatomical abnormalities that may lead to post-operative complications including diminished resistance to infection\n* Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation\n* Acute myocardial infarct (within the previous 6 weeks)\n* Recent cardiac surgery (within the previous 8 weeks)\n* Unstable angina at the time of enrollment\n* History of embolism (cerebrovascular accident, transient ischemic attack, systemic embolism) in the previous 30 days\n* Previous cardiac ablation within the previous 30 days\n* EP ablation within the previous 6 weeks.\n* Life expectancy \\\u003C12 months per the physician opinion.\n* Currently or in the 30 days prior to consent, participation in an interventional clinical trial\n* Significant uncontrolled or unstable medical problems which, in the opinion of the Investigator, would preclude enrollment in and completion of the study (limitation on survival).\n* Any reason or condition that, in the judgement of the investigator, makes the patient ineligible for the investigation.","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval.\n\nThe purpose of MAGiC-FEST PMCF Study is to collect safety and performance data with MAGiC to meet ongoing regulatory obligations.",[27],"Arrhythmias, Cardiac",[29,30,31,32,33,34],"Atrial Fibrillation","Atrial Flutter","Ventricular Tachycardia","Supraventricular Tachycardia","Ablation","Premature Ventricular Contractions","RECRUITING","2026-04-28",{"date":38,"type":39},"2026-05-04","ACTUAL",{"date":41,"type":39},"2024-01-02",{"date":43,"type":21},"2028-12-31",{"name":45,"class":46},"Stereotaxis","INDUSTRY",4,""]