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First-in-Human trial aims to offer new hope for patients with leaky heart valves who Can't have surgery

NCT ID NCT06600191

Recruiting now Disease control Sponsor: Capstan Medical Source: ClinicalTrials.gov ↗

First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This early study tests a new device called the Capstan System, which replaces the mitral valve without open-heart surgery. It is for people with severe mitral regurgitation (a leaky heart valve) who are too sick for traditional surgery. The trial will check if the device can be safely placed and if it improves symptoms.

What this could mean

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

Active substance
a new transcatheter mitral valve replacement device called the Capstan System
What this could lead to
If successful, this could offer a new, less invasive treatment option for people with severe mitral regurgitation who cannot have open-heart surgery.
What could go wrong
This is a very early, first-in-human study with only 10 participants, so safety and effectiveness are not yet established. The procedure carries risks like any heart intervention, including possible device-related 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.

mitral valve insufficiency

As listed by the trial registrant

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

MITRAL REGURGITATION

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Auckland City Hospital

    RECRUITING

    Auckland, 1023, New Zealand

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Monash Health, Victorian Heart Hospital

    NOT_YET_RECRUITING

    Melbourne, Australia

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Pontificia Universidad Católica de Chile

    RECRUITING

    Santiago, Chile

    Contact Phone: •••-•••-•••• Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.