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

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

The PMCF is a prospective, single-arm, multi-center, controlled study of up to 130 patients designed to collect safety and performance data regarding the use of the Adagio VT Cryoablation System in the treatment of recurrent ventricular tachycardia.

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.

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)