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Aortic Valve StenosisDEDICATENCT03112980

Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Low to Intermediate Risk of Mortality

A study testing Transcatheter aortic valve implantation and Surgical aortic valve replacement in people with Aortic Valve Stenosis, run by Universitätsklinikum Hamburg-Eppendorf at 43 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Randomized controlled, multi-center trial randomizing patients with symptomatic severe aortic stenosis at low to intermediate operative risk of mortality in a 1:1 fashion to transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) to test, whether TAVI is non-inferior to SAVR, as… Read more about this study

Who is it for?
Ages 65 to 85 years
Conditions the study is for
Aortic Valve Stenosis
What is being tested?
Transcatheter aortic valve implantation and Surgical aortic valve replacement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,414 participants
Where
43 sitesGermany
Study dates
10 May 2017to Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Heart team consensus that TAVI and SAVR are both medically justified and advisable based on:
  • 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).
  • Patient is symptomatic from his/her aortic valve stenosis
Show all 17Show fewer
  • New York Heart Association Functional Class ≥ II or
  • Angina pectoris or
  • Syncope.
  • 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).
  • 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.
  • Patient has provided written informed consent to participate in the trial.
  • 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.
  • The patient agrees to undergo SAVR, if randomized to control treatment.
  • The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.
  • Patients aged 65 to 85 years.
  • Male patients or females who are postmenopausal defined as no menses for 12 months without an alternative medical cause.

Who cannot join

  • Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
  • Untreated clinically significant coronary artery disease considered a contraindication to an isolated aortic valve procedure (TAVI or SAVR) according to heart team consensus
  • Previous cardiac surgery
  • Any percutaneous coronary intervention performed within 1 month prior to the study procedure
  • Untreated severe mitral or tricuspid regurgitation
  • Untreated severe mitral stenosis
Show all 15Show fewer
  • Hemodynamic instability requiring inotropic support or mechanical circulatory support
  • Ischemic stroke or intracranial bleeding within 1 month
  • Severe ventricular dysfunction with left ventricular ejection fraction < 20% as measured by resting echocardiogram
  • Hypertrophic obstructive cardiomyopathy or severe basal septal hypertrophy with outflow gradient
  • Echocardiographic evidence of an intracardiac mass, thrombus, vegetation or endocarditis
  • Any other condition considered a contraindication for an isolated aortic valve procedure
  • Symptomatic carotid or vertebral artery disease
  • Expected life expectancy < 12 months due to associated non-cardiac comorbidities
  • Currently participating in another investigational drug or device trial

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

Germany43 sites

  • Uniklinik Rheinisch-Westfälische Technische Hochschule Aachen

    Aachen

  • Universitäts-Herzzentrum Freiburg-Bad Krozingen

    Bad Krozingen

  • Kerckhoff-Klinik Bad Nauheim

    Bad Nauheim

  • Herz- und Gefässklinik Bad Neustadt/Saale

    Bad Neustadt an der Saale

  • Herz- und Diabeteszentrum NRW Bad Oeynhausen

    Bad Oeynhausen

  • Charité Universitätsmedizin Berlin (Campus Benjamin-Franklin)

    Berlin

  • Charité Universitätsmedizin Berlin (Campus Mitte)

    Berlin

  • Charité Universitätsmedizin Berlin (Campus Virchow)

    Berlin

  • Deutsches Herzzentrum Berlin

    Berlin

  • Vivantes Friedrichshain

    Berlin

  • Vivantes Humboldt Kliniken

    Berlin

  • Vivantes Klinikum am Urban

    Berlin

  • Vivantes Neukölln

    Berlin

  • Immanuel Klinikum Bernau

    Bernau, 16321

  • Kliniken der Ruhr-Universität Bochum

    Bochum

  • Medizinische Hochschule Brandenburg Theodor Fontane

    Brandenburg an der Havel

  • Herzzentrum der Uniklinik Köln

    Cologne

  • Herzzentrum Dresden an der Technischen Universität Dresden

    Dresden

  • Universitätsklinikum Düsseldorf

    Düsseldorf

  • Universitätsklinikum Erlangen

    Erlangen

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

    Essen

  • Universitätsklinikum Frankfurt

    Frankfurt

  • Universitäts-Herzzentrum Freiburg-Bad Krozingen

    Freiburg im Breisgau

  • Universitätsklinikum Giessen und Marburg

    Giessen

  • Universitätsklinikum Göttingen

    Göttingen

  • Universitätsklinikum Halle (Saale)

    Halle

  • Universitäres Herz- und Gefäßzentrum Hamburg (UHZ)

    Hamburg, Free and Hanseatic City of Hamburg, 20251

  • Medizinische Hochschule Hannover

    Hanover

  • Universitätsklinikum Heidelberg

    Heidelberg

  • Universitätsklinikum Jena

    Jena

  • Universitätsmedizin Greifswald / Klinikum Karlsburg

    Karlsburg

  • Universitätsklinikum Schleswig-Holstein

    Kiel

  • Bundeswehrzentralkrankenhaus Koblenz

    Koblenz, 56076

  • Deutsches Herzzentrum Leipzig

    Leipzig

  • Universitäres Herzzentrum Lübeck

    Lübeck

  • Otto-von Guericke-Universität Magdeburg

    Magdeburg

  • Universitätsmedizin Mainz

    Mainz

  • Deutsches Herzzentrum München

    München

  • LMU Klinikum der Universität München

    München

  • Universitätsklinikum Münster

    Münster

  • Universitätsklinikum Regensburg

    Regensburg

  • Robert Bosch Krankenhaus

    Stuttgart

  • Universitätsklinikum Ulm

    Ulm

Other trials in Germany

About this study

Official title: Randomized, Multi-Center, Event-Driven Trial of TAVI Versus SAVR in Patients With Symptomatic Severe Aortic Valve Stenosis and Intermediate Risk of Mortality, as Assessed by STS-Score - DEDICATE

Randomized controlled, multi-center trial randomizing patients with symptomatic severe aortic stenosis at low to intermediate operative risk of mortality in a 1:1 fashion to transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) to test, whether TAVI is non-inferior to SAVR, as measured by all-cause mortality or stroke after 1 and 5 years.

Read the detailed description

A paradigm-shift towards performing TAVI in intermediate- and low-risk patients has already begun, as procedural results of TAVI have improved significantly within the past years. Nevertheless, a prospective and independent comparison of surgical (SAVR) and interventional (TAVI) valve therapy in patients considered at low to intermediate risk that covers an "all-comers" patient population and multiple devices has not yet been performed.

The DEDICATE-trial is designed as a prospectively randomized (1:1), multi-center, comparator-controlled interventional trial to investigate whether transcatheter aortic valve implantation (TAVI) is non-inferior - as measured by all-cause mortality or stroke after 1 and 5 years - compared to surgical aortic valve replacement (SAVR) in the treatment of patients with symptomatic severe aortic stenosis at low to intermediate operative risk of mortality, as assessed by the local Heart Team.

Being tested
Transcatheter aortic valve implantation, Surgical aortic valve replacement
Keywords
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Surgical aortic valve replacement, Low to intermediate operative risk
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcatheter aortic valve implantationDevice

    (TAVI)

  • Surgical aortic valve replacementProcedure or surgery

    (SAVR)

Study groups in NCT03112980
Study groupRoleWhat they receive
Transcatheter aortic valve implantationExperimentalTranscatheter aortic valve implantation (TAVI) using the most appropriate CE (Conformité Européene)-marked device available, with a minimum demand of experience of 30 implanted devices/type per center.
Receives: Device: Transcatheter aortic valve implantation
Surgical aortic valve replacementActive comparatorSurgical aortic valve replacement (SAVR) with free choice of surgical bioprosthesis and free choice of surgical access according to the surgeon's preference.
Receives: Procedure: Surgical aortic valve replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from stroke or death

    (Efficacy endpoint)

    Measured: within 5 years after randomization

  2. Freedom from stroke or death

    (Safety endpoint)

    Measured: within 1 year after randomization

Secondary outcomes (20)

  1. Freedom from stroke or death

    will be assessed at every study visit and compared between TAVI and SAVR groups

    Measured: Five years after last patient in

  2. Overall survival

    will be assessed at every study visit and compared between TAVI and SAVR groups

    Measured: Five years after last patient in

  3. Freedom from cardiovascular mortality

    will be assessed at every study visit and compared between TAVI and SAVR groups

    Measured: Five years after last patient in

  4. Freedom from the composite of all-cause mortality and stroke

    will be assessed at every study visit and compared between TAVI and SAVR groups

    Measured: Five years after last patient in

  5. Freedom from myocardial infarction

    will be assessed at every study visit and compared between TAVI and SAVR groups

    Measured: Five years after last patient in

  6. Freedom from stroke

    will be assessed at every study visit and compared between TAVI and SAVR groups

    Measured: Five years after last patient in

  7. Freedom from major or life-threatening / disabling bleeding

    will be assessed at every study visit and compared between TAVI and SAVR groups

    Measured: Five years after last patient in

  8. Freedom from acute kidney injury

    will be assessed at every study visit and compared between TAVI and SAVR groups

    Measured: Five years after last patient in

  9. Freedom from vascular access site and access-related complications

    will be assessed at every study visit and compared between TAVI and SAVR groups

    Measured: Five years after last patient in

  10. Freedom from conduction disturbances and arrhythmias, need for permanent pacemaker implantation

    will be assessed at every study visit and compared between TAVI and SAVR groups

    Measured: Five years after last patient in

  11. Freedom from residual aortic regurgitation ≥ moderate

    will be assessed at every study visit and compared between TAVI and SAVR groups

    Measured: Five years after last patient in

  12. Composite device success

    Number of participants with freedom from procedural mortality and correct positioning of a single transcatheter heart valve (THV) in the proper position with intended performance (no prosthesis- patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation)

    Measured: Five years after last patient in

  13. Composite early safety

    Number of participants dying and/or number of participants with stroke (disabling and non-disabling), and/or life-threatening bleeding and/or acute kidney injury stages 2/3 and/or coronary artery obstruction requiring Intervention and/or major vascular complication and/or valve-related dysfunction requiring repeat procedure.

    Measured: within first 30 days after procedure

  14. Composite clinical efficacy

    Number or participants dying and/or number of participants with stroke (disabling and non-disabling) and/or rehospitalisation for worsening heart failure or valve-related symptoms and/or New York Heart Association functional class (NYHA) III or IV and/or valve-related dysfunction (mean aortic valve gradient >20 mmHg, effective orifice area (EOA) <0.9-1.1 cm2 and/or Doppler Velocity Index (DVI) <0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)

    Measured: within first 30 days after procedure

  15. Freedom from prosthetic valve dysfunction

    will be assessed at every study visit and compared between TAVI and SAVR groups

    Measured: Five years after last patient in

  16. Freedom from prosthetic aortic valve endocarditis

    will be assessed at every study visit and compared between TAVI and SAVR groups

    Measured: Five years after last patient in

  17. Freedom from the composite time-related valve safety

    Number of participants with structural valve deterioration (including repeat procedures, prosthetic valve endocarditis and/or thrombosis) and/or number of participants with thromboembolic events (stroke) and/or Valve Academic Research Consortium (VARC-2) bleeding (unless clearly unrelated to valve therapy).

    Measured: Five years after last patient in

  18. Quality of life measures

    Number of participants with reduced quality of life measures after valve replacement as compared to baseline levels prior to valve-replacement, assessed using EuroQol five dimensions (EQ-5D) questionnaire and/or Barthel Index and/or center for epidemiologic studies depression (CES-D) Scale.

    Measured: Five years after last patient in

  19. Health economic analysis

    Incremental cost-effectiveness of TAVI compared to surgical valve replacement, by using quality adjusted life years (QALYs).

    Measured: Five years after last patient in

  20. Number of (re) hospitalisations

    Number rehospitalisations of all participants. Length of stay in hospital

    Measured: Five years after last patient in

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2017
  2. Study start10 May 2017
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,414 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03112980
Sponsor's protocol ID
DEDICATE
Other IDs
DEDICATE - DZHK 6
Acronym
DEDICATE
Status last verified
May 2026
First submitted
21 Mar 2017
Last updated
15 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Seiffert M, Vonthein R, Baumgartner H, Borger MA, Choi YH, Falk V, Frey N, Hagendorff A, Hagl C, Hamm C, Konig IR, Landmesser U, Massberg S, Reichenspurner H, Thiele H, Twerenbold R, Vens M, Walther T, Ziegler A, Cremer J, Blankenberg S. Transcatheter aortic valve implantation versus surgical aortic valve replacement in patients at low to intermediate surgical risk: rationale and design of the randomised DEDICATE Trial. EuroIntervention. 2023 Oct 23;19(8):652-658. doi: 10.4244/EIJ-D-23-00232.

    PubMed 37655862

  • Blankenberg S, Seiffert M, Vonthein R, Baumgartner H, Bleiziffer S, Borger MA, Choi YH, Clemmensen P, Cremer J, Czerny M, Diercks N, Eitel I, Ensminger S, Frank D, Frey N, Hagendorff A, Hagl C, Hamm C, Kappert U, Karck M, Kim WK, Konig IR, Krane M, Landmesser U, Linke A, Maier LS, Massberg S, Neumann FJ, Reichenspurner H, Rudolph TK, Schmid C, Thiele H, Twerenbold R, Walther T, Westermann D, Xhepa E, Ziegler A, Falk V; DEDICATE-DZHK6 Trial Investigators. Transcatheter or Surgical Treatment of Aortic-Valve Stenosis. N Engl J Med. 2024 May 2;390(17):1572-1583. doi: 10.1056/NEJMoa2400685. Epub 2024 Apr 8.

    PubMed 38588025

Questions about this trial

What is this clinical trial studying?

A study testing Transcatheter aortic valve implantation and Surgical aortic valve replacement in people with Aortic Valve Stenosis, run by Universitätsklinikum Hamburg-Eppendorf at 43 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from stroke or death (time frame: within 5 years after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03112980, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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