Ventricular TachycardiaNCT06384599
VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
A study testing VT Cryoablation System in people with Ventricular Tachycardia, run by Adagio Medical at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- VT Cryoablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2027to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Essex Cardiothoracic Centre
Basildon, Essex, SS16 5NL
Neil Srinivasan
About this study
Official title: Adagio Medical VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
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.
Read the detailed description
This VT Post-Market Clinical Follow-up (PMCF) study continues collecting additional information about the Adagio Medical VT Cryoablation System in real world clinical settings.
- Conditions
- Ventricular Tachycardia
- Being tested
- VT Cryoablation System
- Keywords
- Monomorphic Ventricular Tachycardia, VT, Cryoablation
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VT Cryoablation SystemDevice
All subjects will receive a cryoablation procedure using the VT Cryoablation System (catheter, stylets, and console)
| Study group | Role | What they receive |
|---|---|---|
| VT Cryoablation Arm | Experimental | all subjects will receive a cryoablation procedure with the VT System and be followed up for 6-month Receives: Device: VT Cryoablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Performance Endpoint
Freedom from ventricular tachycardia or appropriate ICD intervention until the end of the 6 month follow up period
Measured: 6 months
Primary Safety Endpoint
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).
Measured: 30 Days
Secondary outcomes (2)
Secondary Performance Endpoint
Analysis of the proportion of subjects with non-inducible clinical monomorphic VT at the conclusion of the initial cryotherapy ablation procedure.
Measured: During the procedure
Secondary Safety Endpoint
Freedom from serious adverse events at 6M following discharge.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Jan 2027 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adagio Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384599
- Sponsor's protocol ID
- CS-190
- Status last verified
- Oct 2026
- First submitted
- 18 Apr 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adagio Medical VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
- ClinicalTrials.gov ID
- NCT06384599
- Acronym / sponsor ID
- CS-190
- Conditions
- Ventricular Tachycardia
- Keywords
- Monomorphic Ventricular Tachycardia, VT, Cryoablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Adagio MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This VT Post-Market Clinical Follow-up (PMCF) study continues collecting additional information about the Adagio Medical VT Cryoablation System in real world clinical settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VT Cryoablation Arm | Experimental | Device: VT Cryoablation Systemall subjects will receive a cryoablation procedure with the VT System and be followed up for 6-month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VT Cryoablation SystemAll subjects will receive a cryoablation procedure using the VT Cryoablation System (catheter, stylets, and console) | Device | VT Cryoablation Arm |
Primary outcome
Primary Performance Endpoint
Time frame: 6 months
Freedom from ventricular tachycardia or appropriate ICD intervention until the end of the 6 month follow up period
Primary Safety Endpoint
Time frame: 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).
2 secondary outcomes
Secondary Performance Endpoint
Time frame: During the procedure
Secondary Safety Endpoint
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VT Cryoablation System in people with Ventricular Tachycardia, run by Adagio Medical at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabil Jubran ((949) 348-1188, njubran@adagiomedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Performance Endpoint (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.