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

  • STATUS
    Recruiting
  • End date
    Dec 26, 2026
  • participants needed
    1760
  • sponsor
    Universitätsklinikum Hamburg-Eppendorf
Updated on 26 January 2021
Investigator
Moritz Seiffert, MD
Primary Contact
Universit tsklinikum Erlangen (9.4 mi away) Contact
+87 other location
stenosis
stroke
heart disease
angina pectoris
aortic valve stenosis
aortic valve replacement
transcatheter aortic valve implantation
tavi
valvular disease
syncope

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.

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.

Details
Condition Aortic Stenosis, VALVULAR HEART DISEASE, Heart Valve Disease, aortic valve stenosis
Treatment Surgical aortic valve replacement, Transcatheter Aortic Valve Implantation
Clinical Study IdentifierNCT03112980
SponsorUniversitätsklinikum Hamburg-Eppendorf
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Patients aged 65 to 85 years
Male patients or females who are postmenopausal defined as no menses for 12 months without an alternative medical cause

Exclusion Criteria

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
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