The MAGiC™ Cardiac Ablation European Study

Ki vehet részt

• Adult (aged 18 or older at time of consent)
• 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
• Able to be safely exposed to magnetic fields
• Willing and capable to attend scheduled follow up visits at the study site for the study duration (up to 12 months)
• Willing and able to provide informed consent

Ki nem vehet részt

• Presence of intracardiac thrombus within 12 weeks prior to enrollment
• Acute myocardial infarct (within the previous 6 weeks)
• Recent cardiac surgery (within the previous 8 weeks)
• History of embolism (cerebrovascular accident, transient ischemic attack, systemic embolism) in the previous 30 days
• Previous cardiac ablation within the previous 30 days
• EP ablation within the previous 6 weeks
• Currently or in the 30 days prior to consent, participation in an interventional clinical trial
• A history of sensitivity to foreign objects or extreme allergies
• Acute illness or active systemic infection
• Histological or anatomical abnormalities that may lead to post-operative complications including diminished resistance to infection
• Unstable angina at the time of enrollment
• Any reason or condition that, in the judgement of the investigator, makes the patient ineligible for the investigation
• 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
• 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)
• Unable to remain comfortable or hemodynamically stable in the supine position for an extended period of time
• Weight exceeding 200 kg (the weight limit of the table)
• Where MAGiC would need to cross a prosthetic valve
• Use of MAGiC in the coronary arteries
• Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
• Life expectancy <12 months per the physician opinion
• 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)