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
- Basildon, United KingdomSee the site
- 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)
Where in United Kingdom
- Essex Cardiothoracic CentreBasildon, United KingdomContact: Neil SrinivasanNo longer taking part
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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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