New heart valve fix without open surgery: early trial begins

NCT ID NCT07501234

Recruiting now Disease control Sponsor: Mitrassist Lifesciences Limited Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study is testing a new device called MitraFix® for people with a severe leaky heart valve (mitral regurgitation) who are too high-risk for open-heart surgery. The device is implanted through a small tube in a leg vein. The main goals are to see if the procedure is safe and if the valve works properly. Only 5 participants will be enrolled and followed for one year.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: MitraFix® Transcatheter Mitral Valve System (a device implanted via a leg vein to replace a leaky heart valve)
What this could lead to: If it works, this could offer a less invasive option for people with a severe leaky heart valve who are too frail for open-heart surgery.
What could go wrong: This is a very early feasibility study with only 5 participants, so results may not apply to everyone. The device might not reduce the leak enough or could cause complications like stroke or need for re-operation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

mitral valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MITRAL REGURGITATION (MR)

Contacts and locations

Locations

Fuwai Hospital, Chinese Academy of Medical Sciences
RECRUITING

Beijing, Beijing Municipality, 100037, China

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