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Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

Trial to test Laplace Transcatheter Tricuspid Valve Replacement System.

Recruiting
22-90 years
All
Phase N/A

This study is looking at a new way to fix heart problems using the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System. It is for people who have a condition called tricuspid regurgitation, where one of the heart's valves doesn’t close properly, letting blood flow backward. To join, you must be between 22 and 90 years old, have tried other treatments, and still have symptoms like tiredness or swelling.

Doctors will check your heart with special pictures, like a transthoracic echocardiogram (TTE) or transesophageal echocardiogram (TEE), to see how bad your regurgitation is. You cannot join if you have had a major heart event, like a stroke or heart attack, recently or if you have other serious heart issues.

Key Points:

  • This study is being conducted at multiple centers.
  • You need to be available for all follow-up visits after the procedure.
  • You must agree to the procedure and follow-up by signing informed consent.

Talk to your doctor to see if this study is right for you, and if you have any questions about the procedure or visits, they can help you understand more.

Study details
    Tricuspid Regurgitation

NCT06183684

Laplace Interventional, Inc

30 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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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.

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