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AltaValve Early Feasibility Study Protocol

Join our early study for a new heart valve treatment option.

Recruiting
18 years and older
All
Phase N/A

Study Purpose: This study is trying a new device called the AltaValve to help people with serious heart problems. The heart has a valve that helps blood flow correctly, and sometimes it doesn't work properly, causing mitral valve regurgitation (MR). In this study, doctors want to see if the AltaValve can help people who can't have regular heart surgery because it's too risky for them.

Eligibility: You can join if you’re 18 or older and have serious MR, as shown by a test called an echo. This study is for people who have been told by doctors that surgery is too dangerous for them. You can’t join if you have problems understanding the study or following medical advice, are in another similar study, or have certain allergies.

  • Study Length: Not specified, but participants should be prepared for multiple visits and follow-ups.
  • Participation: You will need to be able to understand the study and agree to participate by signing a consent form.
  • Risks: There are some risks, especially if you have allergies or other health issues, so it’s important to discuss with your doctor.
Study details
    Mitral Regurgitation
    Mitral Insufficiency
    Mitral Valve Incompetence
    Mitral Valve Regurgitation
    Mitral Incompetence

NCT03997305

4C Medical Technologies, Inc.

13 December 2024

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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