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

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ClinicalTrials.gov Identifier: NCT03112980
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
Randomized controlled, multi-center trial randomizing patients with symptomatic severe aortic stenosis at low to intermediate operative risk of mortality, as assessed by the STS-PROM-Score, 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 regarding short and long-term mortality (1 and 5 year).

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: Transcatheter aortic valve implantation Procedure: Surgical aortic valve replacement Not Applicable

Detailed Description:

It is unclear, what the best therapeutic strategy in patients with symptomatic aortic valve stenosis at intermediate risk of perioperative mortality is. While surgical aortic valve replacement (SAVR) is still considered standard of care in low to intermediate risk patients, minimal-invasive transcatheter aortic valve implantation (TAVI) has been shown to be safe and effective in patients deemed inoperable or at high risk of perioperative mortality. Meanwhile, a paradigm-shift in TAVI from inoperable and high-risk towards intermediate risk patients has already begun, despite of lacking evidence in this field.

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 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 Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM)-Score.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024


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)




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Five years after last patient in ]
    Efficacy endpoint

  2. Overall survival [ Time Frame: after at least one year of follow-up after last patient in and 196 deaths of any cause ]
    Safety endpoint (event driven)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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)

  11. 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.

  12. 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)

  13. 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

  14. 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

  15. 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).

  16. 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.

  17. 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).



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 intermediate risk patient according to the current version of the STS-score (risk model for operative mortality: 2-6%, http://riskcalc.sts.org/stswebriskcalc/)
    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 18 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112980


Contacts
Contact: Moritz Seiffert, MD +49 (0) 40 7410 53979 m.seiffert@uke.de
Contact: Stefan Blankenberg, MD +49 (0) 40 7410 53972 s.blankenberg@uke.de

Locations
Germany
Uniklinik Rheinisch-Westfälische Technische Hochschule Aachen Recruiting
Aachen, Germany
Contact: Zakiya Coenen-Basmadjie       zcoenen@ukaachen.de   
Principal Investigator: Nikolaus Marx, MD         
Principal Investigator: Rüdiger Autschbach, MD         
Universitäts-Herzzentrum Freiburg-Bad Krozingen Recruiting
Bad Krozingen, Germany
Contact: Gabriele Lechner       gabriele.lechner@universitaets-herzzentrum.de   
Contact: Monika Bockstatt       monika.bockstatt@universitaets-herzzentrum.de   
Principal Investigator: Franz Josef Neumann, MD         
Principal Investigator: Holger Schröfel, MD         
Kerckhoff-Klinik Bad Nauheim Recruiting
Bad Nauheim, Germany
Contact: A. Kirchhof       a.kirchhof@kerckhoff-fgi.de   
Principal Investigator: Won-Keun Kim, MD         
Herz- und Gefässklinik Bad Neustadt/Saale Recruiting
Bad Neustadt An Der Saale, Germany
Contact: Monika Back       monika.back@herzchirurgie.de   
Principal Investigator: Sebastian Kerber, MD         
Principal Investigator: Anno Diegeler, MD         
Herz- und Diabeteszentrum NRW Bad Oeynhausen Recruiting
Bad Oeynhausen, Germany
Contact: Minko Nnanga       hminko-nnanga@hdz-nrw.de   
Charité Universitätsmedizin Berlin (Campus Benjamin-Franklin) Recruiting
Berlin, Germany
Contact: Anika Maiwald       anika.maiwald@charite.de   
Contact: Lisa Steinbeck       lisa.steinbeck@charite.de   
Principal Investigator: Ulf Landmesser, MD         
Principal Investigator: Volkmar Falk, MD         
Charité Universitätsmedizin Berlin (Campus Mitte) Recruiting
Berlin, Germany
Contact: Christina Berg       christina.berger@charite.de   
Principal Investigator: Karl Stangl, MD         
Principal Investigator: Volkmar Falk, MD         
Charité Universitätsmedizin Berlin (Campus Virchow) Recruiting
Berlin, Germany
Contact: Christina Gaulhofer       christina.gaulhofer@charite.de   
Contact: Jasmin Radenkovic       jasmin.radenkovic@charite.de   
Principal Investigator: Burkert Pieske, MD         
Deutsches Herzzentrum Berlin Recruiting
Berlin, Germany
Contact: Monika Post       post@dhzb.de   
Principal Investigator: Volkmar Falk, MD         
Vivantes Friedrichshain Recruiting
Berlin, Germany
Contact: Martina Gregor       martina.gregor@vivantes.de   
Principal Investigator: Stephan Kische, MD         
Vivantes Humboldt Kliniken Recruiting
Berlin, Germany
Contact: Martina Gregor       martina.gregor@vivantes.de   
Principal Investigator: Steffen Behrens, MD         
Vivantes Klinikum am Urban Recruiting
Berlin, Germany
Contact: Mediha San       viola.jaerisch@vivantes.de   
Principal Investigator: Stephan Kische, MD         
Vivantes Neukölln Recruiting
Berlin, Germany
Contact: Martina Gregor       martina.gregor@vivantes.de   
Principal Investigator: Harald Darius, MD         
Kliniken der Ruhr-Universität Bochum Recruiting
Bochum, Germany
Contact: Bärbel Buchwald       baerbel.buchwald@bergmannsheil.de   
Principal Investigator: Andreas Muegge, MD         
Principal Investigator: Justus Strauch, MD         
Herzzentrum Dresden an der Technischen Universität Dresden Recruiting
Dresden, Germany
Contact: Marion Mai       marion.mai@tu-dresden.de   
Principal Investigator: Axel Linke, MD         
Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, Germany
Contact: Rabea Wagstaff       Rabea.Wagstaff@med.uni-duesseldorf.de   
Principal Investigator: Tobias Zeus, MD         
Principal Investigator: Artur Lichtenberg, MD         
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany
Contact: Sigrun Fechner       sigrun.fechner@uk-erlangen.de   
Contact: Christine Ücker       christine.uecker@uk-erlangen.de   
Principal Investigator: Stefan Achenbach, MD         
Principal Investigator: Michael Weyand, MD         
Universitätsklinikum Frankfurt Recruiting
Frankfurt, Germany
Contact: Vera Jakobi       vera.jakobi@kgu.de   
Principal Investigator: Mariuca Vasa-Nicotera, MD         
Principal Investigator: Nestoras Papadopolous, MD         
Universitätsklinikum Giessen und Marburg Recruiting
Giessen, Germany
Contact: Ursula Böning       ursula.boening@innere.med.uni-giessen.de   
Principal Investigator: Holger Nef, MD         
Principal Investigator: Peter Roth, MD         
Universitätsklinikum Göttingen Recruiting
Göttingen, Germany
Contact: Jessika Jordan       jessika.jordan@med.uni-goettingen.de   
Principal Investigator: Hassina Baraki, MD         
Principal Investigator: Claudius Jacobshagen, MD         
Universitätsklinikum Halle (Saale) Recruiting
Halle (Saale), Germany
Contact: Kathrin Ludwig       kathrin.ludwig@uk-halle.de   
Principal Investigator: Hendrik Treede, MD         
Universitäres Herzzentrum Hamburg (UHZ) Recruiting
Hamburg, Germany, 20251
Contact: Moritz Seiffert, MD    +49 (0) 40 7410 53979    m.seiffert@uke.de   
Principal Investigator: Ulrich Schäfer, MD         
Principal Investigator: Lenard Conradi, MD         
Albertinen Herz- und Gefäßzentrum Hamburg Recruiting
Hamburg, Germany
Contact: Eva Cramer       eva.cramer@albertinen.de   
Principal Investigator: Friedrich Christian Rieß, MD         
Principal Investigator: Joachim Schofer, MD         
Medizinische Hochschule Hannover Recruiting
Hannover, Germany
Contact: Annette Hoffmann-Koch       Hoffmann-Koch.Annette@mh-hannover.de   
Principal Investigator: Johann Bauersachs, MD         
Principal Investigator: Axel Haverich, MD         
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany
Contact: Kathrin Basler       kathrin.basler@med.uni-heidelberg.de   
Principal Investigator: Raffi Bekeredjian, MD         
Principal Investigator: Gabor Szabo, MD         
Universitätsklinikum Jena Recruiting
Jena, Germany
Contact: Sissy Grund       Sissy.Grund@med.uni-jena.de   
Principal Investigator: Christian Schulze, MD         
Principal Investigator: Torsten Doenst, MD         
Universitätsklinikum Schleswig-Holstein Recruiting
Kiel, Germany
Contact: Doreen Brehm       doreen.brehm@uksh.de   
Contact: Petra Röthgen       petra.roethgen@uksh.de   
Principal Investigator: Norbert Frey         
Principal Investigator: Jochen Cremer         
Herzzentrum der Uniklinik Köln Recruiting
Köln, Germany
Contact: Tanja Rudolph       ana.heinrichs@uk-koeln.de   
Contact: Madlen Eichler       madlen.eichler@uk-koeln.de   
Principal Investigator: Stephan Baldus, MD         
Principal Investigator: Thorsten Wahlers, MD         
Deutsches Herzzentrum Leipzig Recruiting
Leipzig, Germany
Contact: Anne-Kathrin Funkat       anne-kathrin.funkat@leipzig-heart.de   
Principal Investigator: Holger Thiele         
Principal Investigator: David Holzhey, MD         
Universitäres Herzzentrum Lübeck Recruiting
Lübeck, Germany
Contact: Jana Peise       jana.peise@uksh.de   
Principal Investigator: Doreen Richardt, MD         
Universitätsmedizin Mainz Recruiting
Mainz, Germany
Contact: Keslin Schulz       Keslin.schulz@unimedizin-mainz.de   
Principal Investigator: Eberhard Schulz, MD         
Principal Investigator: Andres Beiras, MD         
Deutsches Herzzentrum München Recruiting
München, Germany
Contact: Stephanie Simon       simons@dhm.mhn.de   
Principal Investigator: Michael Joner, MD         
Principal Investigator: Sabine Bleiziffer, MD         
LMU Klinikum der Universität München Recruiting
München, Germany
Contact: Melanie Schreiber       Melanie.Schreiber@med.uni-muenchen.de   
Principal Investigator: Steffen Massberg, MD         
Principal Investigator: Christian Hagl, MD         
Universitätsklinikum Münster Recruiting
Münster, Germany
Contact: Antje Hellige       antje.hellige@ukmuenster.de   
Principal Investigator: Helmut Baumgartner, MD         
Principal Investigator: Sven Martens, MD         
Universitätsklinikum Regensburg Recruiting
Regensburg, Germany
Contact: Erika Jäger       erika.jaeger@klinik.uni-regensburg.de   
Principal Investigator: Lars Maier, MD         
Principal Investigator: Christof Schmid, MD         
Herz- und Kreislaufzentrum Rotenburg Recruiting
Rotenburg, Germany
Contact: Tanja Krieg         
Sub-Investigator: Holger Nef, MD         
Principal Investigator: Ardawan Rastan, MD         
Robert Bosch Krankenhaus Recruiting
Stuttgart, Germany
Contact: Ina Wenzelburger       ina.wenzelburger@rbk.de   
Principal Investigator: Tim Schäufele, MD         
Principal Investigator: Ulrich Franke, MD         
Universitätsklinikum Ulm Recruiting
Ulm, Germany
Contact: Uta Dichristin       uta.dichristin@uniklinik-ulm.de   
Principal Investigator: Wolfgang Rottbauer, MD         
Principal Investigator: Andreas Liebold, MD         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Investigators
Principal Investigator: Stefan Blankenberg, MD Universitäres Herzzentrum Hamburg, Germany
Principal Investigator: Jochen Cremer, MD Universitätsklinikum Schleswig-Holstein, Germany

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03112980     History of Changes
Other Study ID Numbers: DEDICATE
DEDICATE - DZHK 6 ( Other Identifier: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) )
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Aortic Valve Stenosis
Transcatheter Aortic Valve Replacement
Surgical aortic valve replacement
Intermediate operative risk

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction