VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study

This VT Post-Market Clinical Follow-up (PMCF) study continues collecting additional information about the Adagio Medical VT Cryoablation System in real world clinical settings.

• VT Cryoablation System (Device): All subjects will receive a cryoablation procedure using the VT Cryoablation System (catheter, stylets, and console)

Primary outcomes

• Primary Performance Endpoint [6 months]: Freedom from ventricular tachycardia or appropriate ICD intervention until the end of the 6 month follow up period
• Primary Safety Endpoint [30 Days]: Freedom from device / procedure related major adverse events (MAE) during and after the ablation procedure through 30 days follow up. MAEs include: * Death * MI * Cardiac perforation / pericardial tamponade * Cerebral infarct or systemic embolism * Major bleeding requiring transfusion * Heart valve damage resulting in moderate to severe regurgitation * Access site complications requiring surgical intervention * Pericarditis * Heart block requiring a pacemaker implant * Other serious adverse device effects (SADEs).

Secondary outcomes

• Secondary Performance Endpoint [During the procedure]: Analysis of the proportion of subjects with non-inducible clinical monomorphic VT at the conclusion of the initial cryotherapy ablation procedure.
• Secondary Safety Endpoint [6 months]: Freedom from serious adverse events at 6M following discharge.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* IC 1 Male or female the ages of ≥ 18 years
* IC 2 Planned ablation procedure according to the indication for use of the Adagio VT Cryoablation System
* IC 3 Subject willing to comply with study requirements and give informed consent
* IC4 Subject has or will be receiving an ICD prior to hospital discharge

Exclusion Criteria:

* EC 1 In the opinion of the investigator, any known contraindication to a ventricular tachycardia procedure with the Adagio VT Cyroablation System as indicated in the device Instructions For Use (IFU)
* EC 2 Subject is enrolled in a study that has not been approved for concurrent enrollment by the sponsor
* EC 3 Any other condition that, in the judgement of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than six months, extensive travel away from the research center)