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Not Yet Recruiting NCT06384599

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

Conditions: Ventricular Tachycardia

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 130
Sponsor: Adagio Medical

Location: Essex Cardiothoracic Centre Basildon Essex

Summary

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.

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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06384599). StuddyBuddy aggregates publicly available trial information.