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
2 other identifiers
interventional
1,414
1 country
43
Brief 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 measured by all-cause mortality or stroke after 1 and 5 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Longer than P75 for not_applicable
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2017
CompletedFirst Posted
Study publicly available on registry
April 13, 2017
CompletedStudy Start
First participant enrolled
May 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
April 26, 2024
April 1, 2024
10.7 years
March 21, 2017
April 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (20)
Freedom from stroke or death
Five years after last patient in
Overall survival
Five years after last patient in
Freedom from cardiovascular mortality
Five years after last patient in
Freedom from the composite of all-cause mortality and stroke
Five years after last patient in
Freedom from myocardial infarction
Five years after last patient in
- +15 more secondary outcomes
Study Arms (2)
Transcatheter aortic valve implantation
EXPERIMENTALTranscatheter 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.
Surgical aortic valve replacement
ACTIVE COMPARATORSurgical aortic valve replacement (SAVR) with free choice of surgical bioprosthesis and free choice of surgical access according to the surgeon's preference.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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.
- +2 more criteria
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Uniklinik Rheinisch-Westfälische Technische Hochschule Aachen
Aachen, Germany
Universitäts-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen, Germany
Kerckhoff-Klinik Bad Nauheim
Bad Nauheim, Germany
Herz- und Gefässklinik Bad Neustadt/Saale
Bad Neustadt an der Saale, Germany
Herz- und Diabeteszentrum NRW Bad Oeynhausen
Bad Oeynhausen, 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
Vivantes Friedrichshain
Berlin, Germany
Vivantes Humboldt Kliniken
Berlin, Germany
Vivantes Klinikum am Urban
Berlin, Germany
Vivantes Neukölln
Berlin, Germany
Immanuel Klinikum Bernau
Bernau, 16321, Germany
Kliniken der Ruhr-Universität Bochum
Bochum, Germany
Medizinische Hochschule Brandenburg Theodor Fontane
Brandenburg, Germany
Herzzentrum der Uniklinik Köln
Cologne, Germany
Herzzentrum Dresden an der Technischen Universität Dresden
Dresden, 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
Universitäts-Herzzentrum Freiburg-Bad Krozingen
Freiburg im Breisgau, Germany
Universitätsklinikum Giessen und Marburg
Giessen, Germany
Universitätsklinikum Göttingen
Göttingen, Germany
Universitätsmedizin Greifswald / Klinikum Karlsburg
Greifswald / Karlsburg, Germany
Universitätsklinikum Halle (Saale)
Halle, Germany
Universitäres Herz- und Gefäßzentrum Hamburg (UHZ)
Hamburg, 20251, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Universitätsklinikum Jena
Jena, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Bundeswehrzentralkrankenhaus Koblenz
Koblenz, 56076, Germany
Deutsches Herzzentrum Leipzig
Leipzig, Germany
Universitäres Herzzentrum Lübeck
Lübeck, Germany
Otto-von Guericke-Universität Magdeburg
Magdeburg, Germany
Universitätsmedizin Mainz
Mainz, Germany
Deutsches Herzzentrum München
München, Germany
LMU Klinikum der Universität München
München, Germany
Universitätsklinikum Münster
Münster, Germany
Universitätsklinikum Regensburg
Regensburg, Germany
Robert Bosch Krankenhaus
Stuttgart, Germany
Universitätsklinikum Ulm
Ulm, Germany
Related Publications (2)
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.
PMID: 37655862BACKGROUNDBlankenberg 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.
PMID: 38588025BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Blankenberg, MD
Universitäres Herz- und Gefäßzentrum Hamburg (UHZ), Germany
- PRINCIPAL INVESTIGATOR
Jochen Cremer, MD
Universitätsklinikum Schleswig-Holstein, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2017
First Posted
April 13, 2017
Study Start
May 10, 2017
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Last Updated
April 26, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share