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

NCT ID NCT06869954

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Presence of fused BAV phenotype with an asymmetric configuration (commissural orientation \< 170 degree) \[14\] 2. Severe aortic regurgitation (vena contracta (vc) \> 6mm and/or pressure half-time (PHT) \< 200 ms and/or effective regurgitant orifice area (EROA) \> 30 mm2 and/or regurgitant volume (RV) \> 60 ml/beat and/or left ventricular end-systolic diameter (LVESD) \> 50mm (or indexed LVESD \> 20mm/m2 BSA) and/or regurgitation fraction (RF) in cardiothoracic MRI \> 40%) (at least one parameter is required) \[15\] 3. Isolated aortic valve surgery or concomitant procedure (including CABG and/or mitral/tricuspid valve surgery and/or ascending aortic surgery) 4. Willingness to participate and written informed consent 5. Age at surgery \> 18 years Exclusion Criteria: 1. Moderate/severe BAV stenosis (pmean \> 20mmHg) 2. Moderate/severe BAV cusp calcifications extending beyond the raphe region and/or necessitating patch implantation (deemed irreparable based on preoperative TOE (as by decision of the operating surgeon) 3. Concomitant aortic root aneurysm \> 45mm requiring simultaneous aortic root surgery \[16\] 4. Acute/subacute BAV endocarditis 5. Contraindication to MRI

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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)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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