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Clinical Trials in the UK / NCT06384599
Starting soon Not applicable

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

NCT06384599 · tracked via the Priya Life Science UK tracker
Sponsor
Adagio Medical
Phase
Not applicable
Started
2027-01-01
Last updated
2026-10-13

Condition(s) studied

Ventricular Tachycardia

Investigational drug(s) / intervention(s)

VT Cryoablation System

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • 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).

Trial sites (1)

FacilityCityRegionStatus
Essex Cardiothoracic Centre Basildon Essex

Other trials for the same condition

Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06384599 on ClinicalTrials.gov ↗ ← All trials in the UK