[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517615":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":117,"collaborators":119,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":125,"sex":131,"minAge":132,"maxAge":20,"enrollmentInfo":133,"targetDuration":20,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Stereotaxis","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Magnetic Interventional Ablation Catheter (MAGiC™)",[13],"Device: 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PhD","+68507609972","eswierzynska@ikard.pl",{"name":116,"role":52,"phone":20,"phoneExt":20,"email":20},"Lukasz Szumowski, MD, PhD",{"type":118,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[120],{"name":121,"class":122},"Osypka AG","UNKNOWN","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":134,"type":135},150,"ESTIMATED","INTERVENTIONAL",[138],"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.",[141],"Arrhythmias, Cardiac",[143,144,145,146,147,148],"Atrial Fibrillation","Atrial Flutter","Ventricular Tachycardia","Supraventricular Tachycardia","Ablation","Premature Ventricular Contractions","2026-04-28",{"date":151,"type":152},"2026-05-04","ACTUAL",{"date":154,"type":152},"2024-01-02",{"date":156,"type":135},"2028-12-31",{"name":5,"class":6},4]