The MAGiC™ Cardiac Ablation European Study

Exclusion Criteria23

• 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)
• For female patients of childbearing potential: pregnancy at the time of the procedure or unwilling to take a pregnancy test
• Presence of intracardiac thrombus at the time of the procedure
• Where MAGiC would need to cross a prosthetic valve
• Use of MAGiC in the coronary arteries
• 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
• Hemodynamic instability
• Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
• Acute myocardial infarct (within the previous 30 days)
• Recent cardiac surgery (within the previous 60 days)
• Unstable angina
• History of embolism (cerebrovascular accident, transient ischemic attack, systemic embolism) in the previous 30 days
• Previous cardiac ablation within the previous 30 days
• Concomitant arrhythmia(s) requiring active treatment at this time or in the 90 days prior to enrollment (Day -90 to Day 0)
• Currently or in the 30 days prior to consent, participation in an interventional clinical trial
• 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).
• Any reason or condition that, in the judgement of the investigator, makes the patient ineligible for the investigation.
• For Atrial Fibrillation only: persistent Atrial Fibrillation (continuous Atrial Fibrillation lasting longer than 7 days)
• For Atrial Fibrillation only: Presence of any device that would interfere with planned access: Patent Foramen Ovale occlusion/closure device, patch