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Massive german study compares new and old heart valve procedures

NCT ID NCT01165827

Knowledge-focused Sponsor: German Aortic Valve Registry Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study was a large registry that planned to follow 180,000 patients in Germany with aortic valve problems (leaky or narrowed valves). The goal was to compare newer, less invasive treatments like TAVI with standard open-heart surgery to see which works best and for whom. Researchers collected data on survival, complications, and quality of life to help doctors make better treatment decisions.

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.

Participants

180,000 people

The number who actually took part.

Started

Jul 2010

Finished

Apr 2026

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.

Who is studied

Patients with Aortic valve procedures from all German hospitals

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: All consecutive patients from participating hospitals with aortic valve defects who have received one of the following therapies: 1. surgical aortic valve replacement, 2. aortic valve surgery (Ross procedure, David procedure) 3. percutaneous transvascular (retrograde) aortic valve implantation 4. percutaneous transapical aortic valve implantation 5. aortic valve valvuloplasty as principal indication. If the aortic valve insufficiency is concurrent with combination procedures (e.g. coronary artery bypass graft, mitral valve surgery) the aortic valve stenosis must fulfil only the criteria for indication according to the German guidelines (Hamm et al. 2008). Exclusion Criteria: * No consent from the patient to collection and analysis of data.

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Conditions

The condition(s) this trial relates to.

aortic valve insufficiency aortic valve stenosis

As listed by the trial registrant

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

Aortic valve insufficiency Aortic valve stenosis

Contacts and locations

Locations

  • BQS Institute for Quality and Patient Safety

    Hamburg, North Rhine-Westphalia, 20537, Germany

More trials for these conditions

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