Medtronic Evaluation of Multi-Electrode Phased RF Technology in Persistent Atrial Fibrillation

The study is expected to be conducted at approximately 40 centers located in Europe, Canada and the United States to support US Food and Drug Administration (FDA) marketing application. A maximum of 350 subjects will be enrolled in the study to ensure 300 subjects can be evaluated for the primary safety endpoint. Subjects will be followed for 30 days post reablation (if reablation required) procedure or 6 months post index procedure (if no reablation procedure required) for the primary safety objective. The primary safety objective will be evaluated after at least 300 ablated subjects complete the 30 day post index or reablation procedure visit and have had the opportunity for a reablation visit. Alternatively, the study may stop early for futility if more than 6 procedure and/or device related strokes occur within the 30 day peri-procedural period prior to completing enrollment. Study subjects from all geographies will be followed for 6 months following their final ablation procedure, or official study closure defined as when Medtronic and/or regulatory requirements have been satisfied per the Clinical Investigational Plan (CIP), whichever occurs first. Accordingly, the expected total study duration is approximately 36 months, representing 24 months of enrollment and up to 12 months of subject follow-up.. The Medtronic Phased RF System is intended to be used for mapping intracardiac electrograms and to deliver precise, temperature controlled radio frequency (RF) ablation therapy within the left atrium of the heart for the treatment of atrial fibrillation. The Phased RF System includes the GENius Multi Channel Radio Frequency Ablation Generator and three anatomically designed, multi-electrode catheters: Pulmonary Vein Ablation Catheter GOLD (PVAC GOLD) Multi-Array Septal Catheter (MASC) Multi-Array Ablation Catheter (MAAC) INCLUSION CRITERIA History of symptomatic persistent or long-standing persistent atrial fibrillation defined as: o Persistent AF: sustained AF lasting 7 days and less than one year, or lasting 7 days but necessitating pharmacologic or electrical cardioversion; OR o Long-standing persistent AF: sustained AF lasting at least 1 year, but no more than 4 years in duration. o Continuous AF as demonstrated on a 48-hour Holter at baseline o AF symptoms defined as the manifestation of: Palpitations Fatigue Exertional dyspnea Increased intolerance to routine activities (exercise intolerance) Age between 18 and 70 Failure of at least one class I or III rhythm control AAD Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study EXCLUSION CRITERIA Structural heart disease of clinical significance including: o Previous cardiac surgery other than CABG or mitral valve repair o NYHA Class III or IV CHF and/or documented ejection fraction 40% measured by acceptable cardiac testing o Left atrial diameter of 55mm o 3+ mitral or aortic valvular heart disease o Stable/unstable angina or ongoing myocardial ischemia o Myocardial infarction (MI) within three months of enrollment o Congenital heart disease other than ASD or PFO without a right to left shunt where the underlying abnormality increases the risk of an ablative procedure o Prior ASD or PFO closure with a device using a percutaneous approach o Hypertrophic cardiomyopathy (LV septal wall thickness 1.5 cm) o Pulmonary hypertension (mean or systolic PA pressure 50mm Hg on Doppler echo) Any prior ablation for atrial fibrillation in the left atrium Enrollment in any other ongoing arrhythmia study protocol Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study Active infection or sepsis Any history of cerebral vascular disease including stroke or TIAs Pregnancy or lactation Left atrial thrombus at the time of ablation Untreatable allergy to contrast media Any diagnosis of atrial fibrillation secondary to electrolyte imba