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

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: Active, not recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Transcatheter aortic valve implantation; Procedure: Surgical aortic valve replacement

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: Interventional
• Enrollment (Actual): 1414
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Freedom from stroke or death	(Efficacy endpoint)	within 5 years after randomization
Freedom from stroke or death	(Safety endpoint)	within 1 year after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from stroke or death	will be assessed at every study visit and compared between TAVI and SAVR groups	Five years after last patient in
Overall survival	will be assessed at every study visit and compared between TAVI and SAVR groups	Five years after last patient in
Freedom from cardiovascular mortality	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	will be assessed at every study visit and compared between TAVI and SAVR groups	Five years after last patient in
Freedom from myocardial infarction	will be assessed at every study visit and compared between TAVI and SAVR groups	Five years after last patient in
Freedom from stroke	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	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	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	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	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	will be assessed at every study visit and compared between TAVI and SAVR groups	Five years after last patient in
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)	Five years after last patient in
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.	within first 30 days after procedure
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)	within first 30 days after procedure
Freedom from prosthetic valve dysfunction	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	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	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	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	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	Number rehospitalisations of all participants. Length of stay in hospital	Five years after last patient in

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: The German Heart Foundation; Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
• Investigators: 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

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2017
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement; Surgical aortic valve replacement; Low to intermediate operative risk
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Surgical Procedures, Operative; Cardiovascular Surgical Procedures; Cardiac Surgical Procedures; Thoracic Surgical Procedures; Prosthesis Implantation; Heart Valve Prosthesis Implantation; Transcatheter Aortic Valve Replacement
• Other Study ID 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