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PRIMARY Ancillary Substudy

Participate in a study to explore new treatment options.

Recruiting
60 years and older
All
Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)

The PRIMARY Ancillary Substudy is part of a larger trial comparing two ways to fix a heart problem called mitral valve prolapse (MVP). MVP can cause mitral regurgitation (MR), where the heart's mitral valve doesn't close tightly, allowing blood to flow backward. This study looks at how these treatments affect the heart's structure and function using various tests like cardiac magnetic resonance imaging (CMR) and transthoracic echocardiogram (TTE). It aims to see if better treatment can help prevent heart failure and irregular heartbeats called arrhythmias.

Key Points:

  • Enrollment is expected to take 12-18 months with participation across several countries.
  • Participants will have rhythm monitoring and some will have pre/post CMR tests.
  • Risks include potential allergic reactions and issues with MRI for some devices.

To join, you must already be enrolled in the main PRIMARY trial. People with severe claustrophobia or certain allergies might be excluded. This study helps us understand how to make heart treatments better and safer!

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Study details
    Mitral Valve Prolapse
    Left Ventricular Fibrosis
    Ventricular Arrhythmias

NCT07103733

Annetine Gelijns

7 March 2026

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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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