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AltaValve Early Feasibility Study Protocol

Join our study exploring new heart valve treatment options.

Recruiting
18 years and older
All
Phase N/A

This study is testing a device called the AltaValve to see if it's safe and works well for people with a heart problem called mitral valve regurgitation. This means their heart valve doesn't close properly, letting blood flow backward. The study is for people who can't have regular heart surgery because it's too risky for them.

To join, you need to be at least 18 years old and have symptoms like tiredness or shortness of breath due to your heart condition. You can't participate if you have trouble understanding the study, are in another study already, or have certain allergies. If you have other serious health problems or are pregnant, you also can't join.

  • This is a single-arm study, meaning everyone gets the same treatment.
  • You'll need approval from a heart team, including a surgeon and a heart doctor.
  • The study takes place at multiple locations.
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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