New trial aims to standardize heart valve repair for common birth defect

NCT ID NCT06869954

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This clinical trial is testing two different surgical methods to repair a bicuspid aortic valve, a common heart defect where the valve has two flaps instead of three. The study will enroll 100 people with this condition who also have a leaky valve (aortic regurgitation). Half will receive an internal ring device, and the other half an external ring, to see which approach leads to better blood flow and less leakage after surgery.

What this could mean

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

Active substance

HAART 200 internal annuloplasty device and external annuloplasty ring

What this could lead to

If successful, this trial could establish a more standardized and effective surgical repair technique for bicuspid aortic valve regurgitation, potentially reducing the need for repeat surgeries.

What could go wrong

This is a relatively small, early-stage trial (100 participants) comparing two surgical methods. The results may not apply to all patients, and both procedures carry standard surgical risks like infection or bleeding.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

aortic valve disease 1 aortic valve disease 2 aortic valve insufficiency Bicuspid Aortic Valve Disease

As listed by the trial registrant

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

Contacts and locations

Study contacts

  • Contact

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

Locations

  • Heart Center Leipzig

    NOT_YET_RECRUITING

    Leipzig, Saxony, 04289, Germany

    Contact

  • Medical Center Hamburg-Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

    Contact Email: •••••@•••••

  • University Heart and Vascular Center Frankfurt

    NOT_YET_RECRUITING

    Frankfurt am Main, Hesse, 60598, Germany

    Contact

  • University Hospital Augsburg

    RECRUITING

    Augsburg, Bavaria, 86156, Germany

    Contact Email: •••••@•••••