Atrial Flutter Ablation in the iCMR (VISABL-AFL)
Atrial Flutter Typical
About this trial
This is an interventional treatment trial for Atrial Flutter Typical focused on measuring RF Ablation, interventional Cardiac Magnetic Resonance (iCMR)
Eligibility Criteria
Inclusion Criteria: 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 Patient 18 years and older Exclusion Criteria: Contraindications for MRI procedures 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 Previous CTI ablation procedures Myocardial infarction within 60 days of enrollment Current unstable angina Cardiac surgery within 90 days of enrollment Any cerebral ischemic event (including transient ischemic attacks) within 6 months (180 days) of enrollment Thrombocytosis or thrombocytopenia Contraindication to anticoagulation therapy Currently documented intracardiac thrombus or myxoma Implantation of permanent leads of an implantable device in or through the right atrium within 90 days of enrollment Prosthetic valve through which the catheter must pass Interatrial baffle or patch through which the catheter must pass Moderate or severe tricuspid valve regurgitation or stenosis Uncompensated congestive heart failure Active systemic infection Pregnancy Uncontrolled hyperthyroidism Any other significant uncontrolled or unstable medical condition Enrollment in any concurrent study without Imricor written approval Life expectancy of less than or equal to 2 years (730 days) per physician opinion
Sites / Locations
Arms of the Study
Arm 1
Experimental
Vision-MR Atrial Flutter Ablation
Type 1 Atrial Flutter ablation performed in the iCMR with the Vision-MR Ablation Catheter 2.0 and associated Advantage-MR EP recorder and stimulator system.