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

Adagio Medical

Status

Not yet enrolling

Conditions

Ventricular Tachycardia

Treatments

Device: VT Cryoablation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT06384599

CS-190

Details and patient eligibility

About

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.

Full description

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.

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)