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Cryoablation device study for repeated ventricular tachycardia, a fast abnormal heartbeat

Tests a freezing catheter system in adults with recurrent ventricular tachycardia.

Key facts

Who runs it
Adagio Medical
Where
United Kingdom1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
Status
Not yet recruiting
People taking part
130 people, planned
Starts
1 Jan 2027
Expected to end
1 Sept 2027
Type of study
Interventional
Treatments tested
  • VT Cryoablation System
Record updated
13 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with recurrent ventricular tachycardia (a fast, abnormal heart rhythm) who are planned to have a cryoablation procedure with the Adagio VT Cryoablation System. Cryoablation uses extreme cold to treat the heart tissue causing the rhythm.

Age
18 years and older
Sex
Men and women can join.
Disease stage
Recurrent ventricular tachycardia, with an ablation procedure planned as the device is meant to be used.
Earlier treatment
People must have an ICD (implanted defibrillator), or get one before leaving the hospital.

Main reasons for not taking part

  • Any known reason, in the device instructions, why the VT procedure with this system cannot be done
  • Taking part in another study not approved by the sponsor
  • Terminal illness with a life expectancy of less than six months
  • Mental illness, addiction, or belonging to a vulnerable patient group
  • Extensive travel away from the research center, or other conditions the study doctor judges make joining hard

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • 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)

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The group in the trial

  • VT Cryoablation ArmTreatment being tested

    all subjects will receive a cryoablation procedure with the VT System and be followed up for 6-month

    Treatment: VT Cryoablation System

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Adagio Medical VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
Plain-language title
Cryoablation device study for repeated ventricular tachycardia, a fast abnormal heartbeatGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
13 October 2026