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Freezing out deadly heart rhythms: new device under study

NCT ID NCT06384599

Disease control Sponsor: Adagio Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a device that uses extreme cold to destroy small areas of heart tissue causing ventricular tachycardia, a fast and dangerous heart rhythm. Up to 130 people with recurrent VT will receive the procedure and be followed for 6 months. The goal is to see if the treatment safely reduces episodes of VT and the need for ICD shocks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VT Cryoablation System (catheter, stylets, and console)
What this could lead to
If it works, this could offer a new way to control dangerous heart rhythms and reduce the need for ICD shocks.
What could go wrong
This is an early post-market study, not a large randomized trial. Risks include serious complications like heart perforation, stroke, or need for a pacemaker.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

ventricular tachycardia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ventricular tachycardia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Essex Cardiothoracic Centre

    Basildon, Essex, SS16 5NL, United Kingdom

More trials for these conditions

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