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

Launched by ADAGIO MEDICAL · Apr 23, 2024

Keywords

ClinConnect Summary

The VT Cryoablation System Post-Market Clinical Follow-up Study is designed to gather important information about the safety and effectiveness of a new treatment for a heart condition called ventricular tachycardia, which causes the heart to beat very quickly. This study will involve up to 130 patients who will be treated with the Adagio VT Cryoablation System, a device that aims to improve heart rhythm. The trial is not yet recruiting participants, but once it starts, it will include men and women aged 18 and older who are scheduled to have this treatment and are willing to participate.

To join the study, participants must be planning to undergo the ablation procedure with the Adagio system and should have or will receive an implantable cardioverter-defibrillator (ICD) before leaving the hospital. However, individuals who have certain health issues that could make the procedure risky or who are involved in other conflicting studies will not be eligible. Participants can expect to follow specific study requirements and will be contributing to important research that could help improve treatment for future patients with this condition.

Gender

ALL

Eligibility criteria

• 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)