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Heart valve showdown: TAVI vs surgery in Mid-Risk patients

NCT ID NCT03112980

Disease control Sponsor: Universitätsklinikum Hamburg-Eppendorf 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two ways to replace a narrowed heart valve in people with severe aortic stenosis who are at intermediate risk for surgery. About 1,400 participants will be randomly assigned to get either a less invasive TAVI procedure or open-heart surgery (SAVR). The main goal is to see if TAVI is as good as surgery at preventing death or stroke over 1 and 5 years.

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

1,414 people

The number who actually took part.

Started

May 2017

Expected to finish

Jan 2028

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

65 to 85 years

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. Heart team consensus that TAVI and SAVR are both medically justified and advisable based on: 1. Degenerative aortic valve stenosis with echocardiographically derived criteria: * Mean gradient \>40 mmHg or * Jet velocity greater than 4.0 m/s or * Aortic valve area (AVA) of \< 1.0 cm2 (indexed effective orifice area \< 0.6cm2/m2). 2. Patient is symptomatic from his/her aortic valve stenosis * New York Heart Association Functional Class ≥ II or * Angina pectoris or * Syncope. 3. Patient is classified as low to intermediate operative risk as assessed by the local heart team according to the variables outlined in the 2017 ESC/EACTS Guidelines for the Management of valvular heart disease, taking into account cardiac and extracardiac Patient characteristics and established risk scores (e.g. STS-PROM, EuroSCORE). 4. A transfemoral or alternative (e.g. transapical, transaortic, transaxillary) access for TAVI seems feasible. Centers should follow a "transfemoral first" strategy for the primary route of access; however, other routes of access are also allowed, as decided by local heart team consensus. 2. Patient has provided written informed consent to participate in the trial. 3. Ability of the patient to understand the patient information and to personally sign and date the informed consent to participate in the study, before performing any study related procedures. 4. The patient agrees to undergo SAVR, if randomized to control treatment. 5. The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits. 6. Patients aged 65 to 85 years. 7. Male patients or females who are postmenopausal defined as no menses for 12 months without an alternative medical cause. Exclusion Criteria: 1. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified 2. Untreated clinically significant coronary artery disease considered a contraindication to an isolated aortic valve procedure (TAVI or SAVR) according to heart team consensus 3. Previous cardiac surgery 4. Any percutaneous coronary intervention performed within 1 month prior to the study procedure 5. Untreated severe mitral or tricuspid regurgitation 6. Untreated severe mitral stenosis 7. Hemodynamic instability requiring inotropic support or mechanical circulatory support 8. Ischemic stroke or intracranial bleeding within 1 month 9. Severe ventricular dysfunction with left ventricular ejection fraction \< 20% as measured by resting echocardiogram 10. Hypertrophic obstructive cardiomyopathy or severe basal septal hypertrophy with outflow gradient 11. Echocardiographic evidence of an intracardiac mass, thrombus, vegetation or endocarditis 12. Any other condition considered a contraindication for an isolated aortic valve procedure 13. Symptomatic carotid or vertebral artery disease 14. Expected life expectancy \< 12 months due to associated non-cardiac comorbidities 15. Currently participating in another investigational drug or device trial

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

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

Aortic valve stenosis

Contacts and locations

Locations

  • Bundeswehrzentralkrankenhaus Koblenz

    Koblenz, 56076, Germany

  • Charité Universitätsmedizin Berlin (Campus Benjamin-Franklin)

    Berlin, Germany

  • Charité Universitätsmedizin Berlin (Campus Mitte)

    Berlin, Germany

  • Charité Universitätsmedizin Berlin (Campus Virchow)

    Berlin, Germany

  • Deutsches Herzzentrum Berlin

    Berlin, Germany

  • Deutsches Herzzentrum Leipzig

    Leipzig, Germany

  • Deutsches Herzzentrum München

    München, Germany

  • Herz- und Diabeteszentrum NRW Bad Oeynhausen

    Bad Oeynhausen, Germany

  • Herz- und Gefässklinik Bad Neustadt/Saale

    Bad Neustadt an der Saale, Germany

  • Herzzentrum Dresden an der Technischen Universität Dresden

    Dresden, Germany

  • Herzzentrum der Uniklinik Köln

    Cologne, Germany

  • Immanuel Klinikum Bernau

    Bernau, 16321, Germany

  • Kerckhoff-Klinik Bad Nauheim

    Bad Nauheim, Germany

  • Kliniken der Ruhr-Universität Bochum

    Bochum, Germany

  • LMU Klinikum der Universität München

    München, Germany

  • Medizinische Hochschule Brandenburg Theodor Fontane

    Brandenburg an der Havel, Germany

  • Medizinische Hochschule Hannover

    Hanover, Germany

  • Otto-von Guericke-Universität Magdeburg

    Magdeburg, Germany

  • Robert Bosch Krankenhaus

    Stuttgart, Germany

  • Uniklinik Rheinisch-Westfälische Technische Hochschule Aachen

    Aachen, Germany

  • Universitäres Herz- und Gefäßzentrum Hamburg (UHZ)

    Hamburg, Free and Hanseatic City of Hamburg, 20251, Germany

  • Universitäres Herzzentrum Lübeck

    Lübeck, Germany

  • Universitäts-Herzzentrum Freiburg-Bad Krozingen

    Bad Krozingen, Germany

  • Universitäts-Herzzentrum Freiburg-Bad Krozingen

    Freiburg im Breisgau, Germany

  • Universitätsklinikum Düsseldorf

    Düsseldorf, Germany

  • Universitätsklinikum Erlangen

    Erlangen, Germany

  • Universitätsklinikum Essen, Klinikum für Kardiologie und Angiologie am Westdeutschen Herz- und Gefäßzentrum

    Essen, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt, Germany

  • Universitätsklinikum Giessen und Marburg

    Giessen, Germany

  • Universitätsklinikum Göttingen

    Göttingen, Germany

  • Universitätsklinikum Halle (Saale)

    Halle, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, Germany

  • Universitätsklinikum Jena

    Jena, Germany

  • Universitätsklinikum Münster

    Münster, Germany

  • Universitätsklinikum Regensburg

    Regensburg, Germany

  • Universitätsklinikum Schleswig-Holstein

    Kiel, Germany

  • Universitätsklinikum Ulm

    Ulm, Germany

  • Universitätsmedizin Greifswald / Klinikum Karlsburg

    Karlsburg, Germany

  • Universitätsmedizin Mainz

    Mainz, Germany

  • Vivantes Friedrichshain

    Berlin, Germany

  • Vivantes Humboldt Kliniken

    Berlin, Germany

  • Vivantes Klinikum am Urban

    Berlin, Germany

  • Vivantes Neukölln

    Berlin, Germany

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