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

May 14, 2026 updated by: Universitätsklinikum Hamburg-Eppendorf

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1414

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany
        • Uniklinik Rheinisch-Westfälische Technische Hochschule Aachen
      • Bad Krozingen, Germany
        • Universitäts-Herzzentrum Freiburg-Bad Krozingen
      • Bad Nauheim, Germany
        • Kerckhoff-Klinik Bad Nauheim
      • Bad Neustadt an der Saale, Germany
        • Herz- und Gefässklinik Bad Neustadt/Saale
      • Bad Oeynhausen, Germany
        • Herz- und Diabeteszentrum NRW Bad Oeynhausen
      • Berlin, Germany
        • Vivantes Klinikum am Urban
      • Berlin, Germany
        • Deutsches Herzzentrum Berlin
      • Berlin, Germany
        • Charité Universitätsmedizin Berlin (Campus Benjamin-Franklin)
      • Berlin, Germany
        • Charité Universitätsmedizin Berlin (Campus Mitte)
      • Berlin, Germany
        • Charité Universitätsmedizin Berlin (Campus Virchow)
      • Berlin, Germany
        • Vivantes Friedrichshain
      • Berlin, Germany
        • Vivantes Humboldt Kliniken
      • Berlin, Germany
        • Vivantes Neukölln
      • Bernau, Germany, 16321
        • Immanuel Klinikum Bernau
      • Bochum, Germany
        • Kliniken der Ruhr-Universität Bochum
      • Brandenburg an der Havel, Germany
        • Medizinische Hochschule Brandenburg Theodor Fontane
      • Cologne, Germany
        • Herzzentrum der Uniklinik Köln
      • Dresden, Germany
        • Herzzentrum Dresden an der Technischen Universität Dresden
      • Düsseldorf, Germany
        • Universitätsklinikum Düsseldorf
      • Erlangen, Germany
        • Universitätsklinikum Erlangen
      • Essen, Germany
        • Universitätsklinikum Essen, Klinikum für Kardiologie und Angiologie am Westdeutschen Herz- und Gefäßzentrum
      • Frankfurt, Germany
        • Universitätsklinikum Frankfurt
      • Freiburg im Breisgau, Germany
        • Universitäts-Herzzentrum Freiburg-Bad Krozingen
      • Giessen, Germany
        • Universitätsklinikum Gießen und Marburg
      • Göttingen, Germany
        • Universitätsklinikum Göttingen
      • Halle, Germany
        • Universitätsklinikum Halle (Saale)
      • Hanover, Germany
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany
        • Universitätsklinikum Heidelberg
      • Jena, Germany
        • Universitätsklinikum Jena
      • Karlsburg, Germany
        • Universitätsmedizin Greifswald / Klinikum Karlsburg
      • Kiel, Germany
        • Universitätsklinikum Schleswig-Holstein
      • Koblenz, Germany, 56076
        • Bundeswehrzentralkrankenhaus Koblenz
      • Leipzig, Germany
        • Deutsches Herzzentrum Leipzig
      • Lübeck, Germany
        • Universitäres Herzzentrum Lübeck
      • Magdeburg, Germany
        • Otto-von Guericke-Universität Magdeburg
      • Mainz, Germany
        • Universitätsmedizin Mainz
      • München, Germany
        • Deutsches Herzzentrum München
      • München, Germany
        • LMU Klinikum der Universität München
      • Münster, Germany
        • Universitätsklinikum Münster
      • Regensburg, Germany
        • Universitätsklinikum Regensburg
      • Stuttgart, Germany
        • Robert Bosch Krankenhaus
      • Ulm, Germany
        • Universitatsklinikum Ulm
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Germany, 20251
        • Universitäres Herz- und Gefäßzentrum Hamburg (UHZ)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

61 years to 81 years (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Transcatheter aortic valve implantation
Transcatheter 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.
Device: Transcatheter aortic valve implantation
(TAVI)
Active Comparator: Surgical aortic valve replacement
Surgical aortic valve replacement (SAVR) with free choice of surgical bioprosthesis and free choice of surgical access according to the surgeon's preference.
Procedure: Surgical aortic valve replacement
(SAVR)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Freedom from stroke or death
Time Frame: within 5 years after randomization
(Efficacy endpoint)
within 5 years after randomization
Freedom from stroke or death
Time Frame: within 1 year after randomization
(Safety endpoint)
within 1 year after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Freedom from stroke or death
Time Frame: Five years after last patient in
will be assessed at every study visit and compared between TAVI and SAVR groups
Five years after last patient in
Overall survival
Time Frame: Five years after last patient in
will be assessed at every study visit and compared between TAVI and SAVR groups
Five years after last patient in
Freedom from cardiovascular mortality
Time Frame: Five years after last patient in
will be assessed at every study visit and compared between TAVI and SAVR groups
Five years after last patient in
Freedom from the composite of all-cause mortality and stroke
Time Frame: Five years after last patient in
will be assessed at every study visit and compared between TAVI and SAVR groups
Five years after last patient in
Freedom from myocardial infarction
Time Frame: Five years after last patient in
will be assessed at every study visit and compared between TAVI and SAVR groups
Five years after last patient in
Freedom from stroke
Time Frame: Five years after last patient in
will be assessed at every study visit and compared between TAVI and SAVR groups
Five years after last patient in
Freedom from major or life-threatening / disabling bleeding
Time Frame: Five years after last patient in
will be assessed at every study visit and compared between TAVI and SAVR groups
Five years after last patient in
Freedom from acute kidney injury
Time Frame: Five years after last patient in
will be assessed at every study visit and compared between TAVI and SAVR groups
Five years after last patient in
Freedom from vascular access site and access-related complications
Time Frame: Five years after last patient in
will be assessed at every study visit and compared between TAVI and SAVR groups
Five years after last patient in
Freedom from conduction disturbances and arrhythmias, need for permanent pacemaker implantation
Time Frame: Five years after last patient in
will be assessed at every study visit and compared between TAVI and SAVR groups
Five years after last patient in
Freedom from residual aortic regurgitation ≥ moderate
Time Frame: Five years after last patient in
will be assessed at every study visit and compared between TAVI and SAVR groups
Five years after last patient in
Composite device success
Time Frame: Five years after last patient in
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)
Five years after last patient in
Composite early safety
Time Frame: within first 30 days after procedure
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.
within first 30 days after procedure
Composite clinical efficacy
Time Frame: within first 30 days after procedure
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)
within first 30 days after procedure
Freedom from prosthetic valve dysfunction
Time Frame: Five years after last patient in
will be assessed at every study visit and compared between TAVI and SAVR groups
Five years after last patient in
Freedom from prosthetic aortic valve endocarditis
Time Frame: Five years after last patient in
will be assessed at every study visit and compared between TAVI and SAVR groups
Five years after last patient in
Freedom from the composite time-related valve safety
Time Frame: Five years after last patient in
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).
Five years after last patient in
Quality of life measures
Time Frame: Five years after last patient in
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.
Five years after last patient in
Health economic analysis
Time Frame: Five years after last patient in
Incremental cost-effectiveness of TAVI compared to surgical valve replacement, by using quality adjusted life years (QALYs).
Five years after last patient in
Number of (re) hospitalisations
Time Frame: Five years after last patient in
Number rehospitalisations of all participants. Length of stay in hospital
Five years after last patient in

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The German Heart Foundation
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefan Blankenberg, MD, Universitäres Herz- und Gefäßzentrum Hamburg (UHZ), Germany
  • Principal Investigator: Jochen Cremer, MD, Universitätsklinikum Schleswig-Holstein, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DEDICATE
  • DEDICATE - DZHK 6 (Other Identifier: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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