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Autus Valve Pivotal Study

Autus Valve Study: Researching heart valve treatments.

Recruiting
18-16 years
All
Phase N/A

Autus Valve Pivotal Study is a research project to test a new heart valve in children aged 18 months to 16 years who need pulmonary valve replacement surgery. The pulmonary valve helps blood flow from the heart to the lungs. The study uses the Autus Size-Adjustable Valve, which can be resized before and after being placed in the body. This valve can grow with the child, which means fewer surgeries in the future. Children will be checked before getting the valve, right after, at hospital release, 30 days later, 6 months later, and then once a year for 10 years. If the valve is resized later, check-ups will continue for at least another year.

  • The study lasts up to 10 years with regular check-ups.
  • Participants must be willing to attend all follow-up visits.
  • Consider risks like potential need for more surgeries or infection.

If you have questions or think you might qualify, talk to your doctor. They can help determine if this study is a good fit for you.

Study details
    Congenital Heart Disease

NCT05006404

Autus Valve Technologies, Inc.

11 January 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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