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New heart valve implant could offer hope for leaky aortic valve patients

NCT ID NCT04864145

Recruiting now Disease control Sponsor: Nanjing First Hospital, Nanjing Medical University Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a new, less invasive heart valve implant (TAVR) with standard medication for people who have severe aortic regurgitation, a condition where the heart's aortic valve doesn't close properly. The trial will enroll 210 participants across multiple centers. The goal is to see if the implant reduces the risk of death, disabling stroke, or heart failure hospitalization compared to medication alone.

What this could mean

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

Active substance
Transcatheter Aortic Valve Implantation (TAVR) device (VitaFlow system)
What this could lead to
If successful, this could provide a less invasive treatment option for people with severe aortic regurgitation who are not candidates for open-heart surgery.
What could go wrong
This is a relatively early study with 210 participants, so results may not apply to everyone. The procedure carries risks like bleeding, need for a permanent pacemaker, or other complications.

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.

Aortic Valve Disease aortic valve disorder aortic valve insufficiency

As listed by the trial registrant

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

AORTIC VALVE DISEASE

Contacts and locations

Locations

  • Nanjing First Hospital

    RECRUITING

    Nanjing, Jiangsu, 210006, China

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