New heart valve design aims to simplify replacements and cut risks

NCT ID NCT04442100

Recruiting now Disease control Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences Source: ClinicalTrials.gov ↗

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

Summary

This study is testing a new type of biological heart valve that features an 'easy change' system, designed to make future replacements simpler. Researchers will implant these valves in 500 people with aortic valve disease and track complications like blood clots, infections, and valve wear over time. The goal is to see if the new design improves safety and outcomes compared to standard valves.

What this could mean

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

Active substance: biological prosthetic heart valves (MedEng-Bio)
What this could lead to: If successful, this could make heart valve replacements easier to perform and reduce serious complications like blood clots or infections.
What could go wrong: This is an early study without a control group, so results may not prove the new valve is better than existing options. Risks include typical surgery complications like bleeding or valve failure over time.

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Conditions

The condition(s) this trial relates to.

aortic valve disorder heart valve disorder mitral valve disorder

As listed by the trial registrant

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

HEART VALVE DISEASES

Contacts and locations

Locations

Tomsk National Research Medical Center of the Russian Academy of Sciences
RECRUITING

Tomsk, Tomsk Oblast, 634012, Russia

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