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Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)

Study on mitral valve repair for patients 60 and older.

Recruiting
65 years and older
All
Phase N/A

This study looks at how well two different treatments work for fixing a heart valve problem called mitral regurgitation (MR) in people 60 years or older. MR happens when the mitral valve, a valve in the heart, doesn’t close properly, causing blood to flow backward. The study compares two treatments: one is a **surgical repair** where doctors fix the valve through surgery, and the other is a **transcatheter edge-to-edge repair (TEER)**, which is less invasive and uses a tube to reach the heart and repair the valve.

The study will happen in the U.S., Canada, Germany, and the UK. It will track how patients do over a long time, up to 10 years, to see which treatment is safer and more effective. The study will last for 5 years after treatment, with patients being watched closely to see how their heart health improves.

  • Trial Duration: 5 years post-treatment, with follow-ups for up to 10 years.
  • Eligibility: Adults 65+ with severe MR, able to do a 6-minute walk test.
  • Risks/Benefits: Comparing safety and effectiveness of surgical vs. less invasive TEER.
Study details
    Mitral Valve Regurgitation

NCT05051033

Annetine Gelijns

29 March 2025

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