Clinical Trial: Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Intermediate Risk of Mortality

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: Randomized controlled, multi-center trial randomizing patients with symptomatic severe aortic stenosis at 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).

Detailed Summary:

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 intermediate operative risk of mortality, as assessed by the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM)-Score.


Sponsor: Universitätsklinikum Hamburg-Eppendorf

Current Primary Outcome:

  • Overall survival [ Time Frame: Five years after last patient in ]
    Efficacy endpoint
  • 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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.
  • 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)
  • 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
  • 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
  • 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).
  • 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.
  • Health economic analysis [ Time Frame: Five years after last patient in ]
    Same as current

    Information By: Universitätsklinikum Hamburg-Eppendorf

    Dates:
    Date Received: March 21, 2017
    Date Started: April 2017
    Date Completion: May 2023
    Last Updated: May 24, 2017
    Last Verified: May 2017