All studies
RecruitingNAINTERVENTIONAL

Cryoablation for Monomorphic Ventricular Tachycardia

This study is investigating a new procedure called cryoablation, which uses freezing energy to treat a specific type of fast or irregular heartbeat called monomorphic ventricular tachycardia (VT). This VT happens when the heart's electrical signals go wrong, often due to scarring in the heart muscle. The main goal of this research is to check if this freezing treatment, using a device called the Adagio VT Cryoablation System, is both safe and effective for patients. They are particularly interested in people who experience recurring VT and already have an implanted device (ICD) to help manage their heart rhythm. The study will carefully look at how well the new treatment works and if there are any side effects.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Adagio Medical
Enrolment target
206
Start
11 Sep 2023
Estimated completion
30 Mar 2027

What is this study about?

This research study is looking into a new way to treat a specific type of irregular heartbeat called monomorphic ventricular tachycardia (VT). VT happens when the lower chambers of your heart beat very fast. In this study, they are focusing on VT that is caused by areas of scarring in the heart muscle, which can happen after a heart attack or due to other heart conditions. The treatment being tested is called cryoablation, which uses very cold temperatures to create tiny scars to block the abnormal electrical signals causing the VT.

The study wants to find out if this cryoablation treatment, using a special device called the Adagio VT Cryoablation System, is a safe and effective option for people who have recurring episodes of this type of VT. They are looking for participants who have VT that hasn't been controlled by other treatments or who can't take certain medications. All participants will have an implantable cardioverter defibrillator (ICD) already in place, which is a small device that can correct dangerous heart rhythms.

Ultimately, the researchers hope to gather enough information about the safety and success of this new cryoablation system so that it can become a widely available treatment option for patients experiencing this challenging heart condition. By studying it carefully, they aim to improve care for people living with recurring VT.

Key takeaways

  • This study is testing a new 'freezing' treatment for a specific type of fast heartbeat (VT).
  • It's for people whose VT is caused by heart scarring and haven't responded well to other treatments.
  • Participants must already have an Implantable Cardioverter Defibrillator (ICD).
  • The main goal is to check if this new treatment is safe and works effectively.
  • Participation involves a procedure and regular check-ups to monitor your heart.
  • You can withdraw from the study at any time if you change your mind.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. You must have scarring in your heart muscle that is causing recurrent, bothersome episodes of a specific type of fast heart rhythm called monomorphic ventricular tachycardia (VT). This heart scarring can be due to a previous heart attack or other heart problems, and doctors would typically recommend an ablation procedure for your condition.

You also need to have an Implantable Cardioverter Defibrillator (ICD) already fitted, which helps manage dangerous heart rhythms. Furthermore, you should have experienced at least one episode of this specific VT in the last six months and either found that your current medications aren't working well enough, or you can't tolerate their side effects. The study also needs you to be able and willing to attend all scheduled appointments and give your informed consent.

There are some conditions that would prevent you from joining. These include having a blood clot in your heart, having VT caused by reasons other than scarring (like very specific types of fast heartbeats or problems with your body's chemistry), or if your VT problem is only on the outer surface of your heart. Specific types of VT that aren't caused by scar tissue or are linked to other conditions like electrolyte imbalances would also mean you couldn't take part.

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.

  1. Are you 18 years old or older?
  2. Do you have recurrent, bothersome fast heartbeats (VT) caused by heart scarring?
  3. Do you already have an Implantable Cardioverter Defibrillator (ICD)?
  4. Have other treatments for your VT either not worked well or caused difficult side effects?
  5. Are you able and willing to attend all study appointments?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will undergo a cryoablation procedure using the Adagio VT Cryoablation System. Before and after the procedure, you will have several appointments where the study team will monitor your health, heart rhythm, and the effectiveness of the treatment. These appointments will involve check-ups and possibly some tests to see how you are responding to the procedure and to look for any side effects. The study has two phases, an initial safety check and then a larger phase to gather more information, meaning your follow-up will continue for a certain period to track your progress. The total duration of your participation, including all follow-up visits, will be explained in detail by the study team, but it will last for a sustained period to collect all necessary safety and effectiveness data. You won't be expected to take any new study medications, as the focus is on the cryoablation procedure itself.

Potential risks and benefits

Taking part in this study might offer a potential benefit if the cryoablation procedure helps to reduce your episodes of ventricular tachycardia, especially if other treatments haven't worked well for you. However, as with any medical procedure, there are potential risks, including those commonly associated with heart procedures like bleeding, infection, and potential damage to heart tissue. The study team will explain all known risks in detail. It’s important to remember that participation is completely voluntary; you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (15)

  • Banner University Medical Center Phoenix
    Verified postcode
    Phoenix, United States· Recruiting
  • University of California San Francisco
    Verified postcode
    San Francisco, United States· Recruiting
  • Johns Hopkins University
    Verified postcode
    Baltimore, United States· Recruiting
  • Brigham and Women's Hospital
    Verified postcode
    Boston, United States· Recruiting
  • University of Michigan
    Verified postcode
    Ann Arbor, United States· Recruiting
  • Icahn School of Medicine at Mount Sinai
    Verified postcode
    New York, United States· Recruiting
  • Weill Cornell Medical Center
    Verified postcode
    New York, United States· Recruiting
  • Northwell Health- Staten Island University Hospital
    Verified postcode
    Staten Island, United States· Recruiting
  • Ohio State University
    Verified postcode
    Columbus, United States· Recruiting
  • Hospital of University of Pennsylvania
    Verified postcode
    Philadelphia, United States· Recruiting
  • Medical Center of South Carolina (MUSC)
    Verified postcode
    Charleston, United States· Recruiting
  • Vanderbilt University Medical Center
    Verified postcode
    Nashville, United States· Recruiting

Common questions

What is cryoablation?

Cryoablation is a medical procedure that uses extremely cold temperatures to freeze and destroy small areas of tissue that are causing problems, in this case, abnormal heart rhythms.

What is ventricular tachycardia (VT)?

Ventricular tachycardia (VT) is a type of fast or irregular heartbeat originating from the lower chambers of your heart. It can sometimes be quite serious.

What is an ICD?

An ICD stands for Implantable Cardioverter Defibrillator. It's a small device placed under your skin that can detect and correct dangerous fast heart rhythms by delivering electrical shocks.

Will I have to stop my current medications?

The study aims to see if cryoablation helps when current medications aren't working or are causing problems. Any changes to your medication will be discussed and decided by your study doctor.

How long will I be in the study?

The exact duration of your participation, including all follow-up appointments, will be explained by the study team. It will involve a period of monitoring to ensure the treatment is safe and effective.

How to find out more

Nabil Jubran

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

Interested in taking part?

Register your interest

Share your details and the research team for "Cryoablation for Monomorphic Ventricular Tachycardia…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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