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Trial record 1 of 1 for:    NCT03112980
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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 27, 2019
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 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 after 1 and 5 years.

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

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 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 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.

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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

Resource links provided by the National Library of Medicine


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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   70 Years to 85 Years   (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 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 70 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
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Contact: Moritz Seiffert, MD +49 (0) 40 7410 58206 m.seiffert@uke.de
Contact: Stefan Blankenberg, MD +49 (0) 40 7410 53972 s.blankenberg@uke.de

Locations
Show Show 40 study locations
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Investigators
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Principal Investigator: Stefan Blankenberg, MD Universitäres Herzzentrum Hamburg, Germany
Principal Investigator: Jochen Cremer, MD Universitätsklinikum Schleswig-Holstein, Germany
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03112980    
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 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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