Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT)

Primary Outcomes (3)

• Proportion of Subjects Who Are Free From Definite or Probable Device/Procedure Related Major Adverse Events (MAEs)

  An analysis of the proportion of subjects who are free from definite or probable device/procedure related Major Adverse Events (MAEs) that occur during or within 30 days following the cryoablation procedure. MAEs include any of the following: * Death * Myocardial infarction * Cardiac perforation/pericardial tamponade * Cerebral infarct or systemic embolism * Major bleeding requiring transfusion * Mitral, Tricuspid or Aortic valve damage resulting in moderate or severe regurgitation * Access site complications requiring medical or surgical intervention * Pericarditis * Heart block requiring a permanent pacemaker * Other serious adverse device effects (SADEs), including TIAs, adjudicated by an independent DSMB to be probably or definitely related to the Adagio System.

  during or within 30 days following the cryoablation procedure

• 6-month Freedom From Sustained VT (>30 s) or Appropriate ICD Intervention (Shock or Anti-tachycardia Pacing)

  The primary clinical performance endpoint is an analysis of the proportion of patients receiving a single cryoablation procedure with freedom from ventricular tachycardia lasting longer than 30 seconds or appropriate ICD intervention until the end of the 6 month follow up period.

  6 month post cryoablation procedure

• Proportion of Patients With Non-inducible Clinical VT at the Conclusion of the Ablation Procedure

  The primary procedural performance endpoint is an analysis of the proportion of subjects with non-inducible clinical monomorphic VT at the conclusion of the initial cryoablation procedure.

  at the end of the cryoablation procedure