Not yet recruitingNAINTERVENTIONAL

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

This study is checking a new treatment called the Adagio VT Cryoablation System, which uses very cold temperatures to treat a heart condition called ventricular tachycardia (VT). VT makes your heart beat too fast and can be serious. This research is called a 'post-market clinical follow-up' study, meaning the treatment system is already available, and doctors want to gather more information on how well it works and if it's safe in everyday clinical practice across different hospitals. The study aims to follow up to 130 patients who are having this procedure to help improve heart care for people with VT.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Adagio Medical

Enrolment target

130

Start

01 Sep 2026

Estimated completion

01 Sep 2027

Ventricular Tachycardia

What is this study about?

This study is all about a new type of heart treatment for a condition called ventricular tachycardia (VT). VT is when the lower chambers of your heart beat very quickly, which can make you feel dizzy, breathless, or even faint. It's a serious condition that needs careful management.

The new treatment being looked at is called the Adagio VT Cryoablation System. 'Cryoablation' means using extremely cold temperatures to create tiny scars on the areas of the heart that are causing the fast rhythm. These scars block the electrical signals that make the heartbeat irregular, helping your heart go back to a normal rhythm. This study isn't testing something completely new; rather, it’s gathering more information about a treatment system that’s already in use. It helps doctors understand how well it works and how safe it is for patients in real-world hospital settings.

By carefully watching patients who receive this treatment, the study aims to confirm its safety and effectiveness. The information collected will help medical professionals better understand how to use the system to help people with ventricular tachycardia. It's an important step in ensuring that heart treatments are as good and as safe as possible for everyone.

Key takeaways

The study is about a freezing treatment for a fast heart rhythm (VT).
It aims to check the safety and effectiveness of the Adagio VT Cryoablation System in real hospitals.
Participation involves having the procedure and follow-up check-ups.
You must be 18 or older and scheduled for this specific procedure.
An ICD implant is usually required before or after the procedure.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. You would be considered if your doctor has already planned for you to have the Adagio VT Cryoablation System treatment for your fast heart rhythm (ventricular tachycardia).

It's also important that you are willing and able to follow all the study instructions and attend any necessary appointments. Before you leave the hospital, you'll also need to have an implantable cardioverter-defibrillator (ICD) placed, or already have one.

There are some reasons why you might not be able to join. For example, if your doctor believes this procedure isn't suitable for you, or if you have certain other serious health issues that might make taking part difficult or unsafe. You also can't be in another study at the same time unless it's been specifically approved.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Has your doctor planned for you to have the Adagio VT Cryoablation procedure?
Are you able and willing to attend all study appointments and follow instructions?
Do you have, or will you be getting, an ICD (a heart device) before leaving the hospital?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll receive the Adagio VT Cryoablation treatment for your ventricular tachycardia as planned by your doctor. The study will then involve following up with you to see how you are doing after the procedure. This will likely include regular check-ups at the hospital or clinic, which might involve tests like ECGs (heart traces) or device checks for your ICD to see how your heart rhythm is doing. The full duration of your participation will be explained to you by the study team, but it will involve ongoing monitoring after your procedure.

Potential risks and benefits

Participating in this study might offer you the benefit of close monitoring of your heart condition and treatment. The procedure itself aims to improve your heart rhythm. However, as with any medical procedure, there are potential risks associated with the cryoablation treatment and the follow-up tests, which your doctor will explain in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Essex Cardiothoracic Centre
Verified postcode
Basildon, United Kingdom

Common questions

What is ventricular tachycardia (VT)?

VT is a type of fast heart rhythm that starts in the lower chambers of your heart, making it beat too quickly.

What is cryoablation?

Cryoablation uses very cold temperatures to create small scars in your heart, which helps to stop the irregular electrical signals causing VT.

Is this a brand new treatment?

No, this study is collecting more information about a treatment system (Adagio VT Cryoablation System) that is already being used in hospitals, to ensure it's safe and works well in real-life settings.

How many patients are in this study?

The study aims to follow up to 130 patients who are receiving this treatment.

Will I get special treatment if I join?

You will receive the planned cryoablation procedure, and the study will involve extra follow-up appointments and checks to monitor your progress.

How to find out more

Nabil Jubran

njubran@adagiomedical.com (949) 348-1188 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.