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

NCT ID NCT06869954

Recruiting now Disease control Sponsor: University Hospital Augsburg Source: ClinicalTrials.gov ↗

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.

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 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.

AORTIC REGURGITATION DISEASE BICUSPID AORTIC VALVE (BAV)

Contacts and locations

Locations

Heart Center Leipzig
NOT_YET_RECRUITING

Leipzig, Saxony, 04289, Germany
Medical Center Hamburg-Eppendorf
RECRUITING

Hamburg, 20246, Germany
University Heart and Vascular Center Frankfurt
NOT_YET_RECRUITING

Frankfurt am Main, Hesse, 60598, Germany
University Hospital Augsburg
RECRUITING

Augsburg, Bavaria, 86156, Germany

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