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Clinical Trials in Germany / NCT03112980
Active, not recruiting Not applicable

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

NCT03112980 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2017-05-10
Last updated
2026-05-15

Condition(s) studied

Aortic Valve Stenosis

Investigational drug(s) / intervention(s)

Transcatheter aortic valve implantationSurgical aortic valve replacement

Transcatheter aortic valve implantation: (TAVI)

Surgical aortic valve replacement: (SAVR)

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
85 Years
Healthy volunteers
No
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 65 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

Primary outcome measure(s)

Trial sites (43)

FacilityCityRegionStatus
Universitäres Herz- und Gefäßzentrum Hamburg (UHZ) Hamburg Free and Hanseatic City of Hamburg
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 Germany
Kliniken der Ruhr-Universität Bochum Bochum Germany
Medizinische Hochschule Brandenburg Theodor Fontane Brandenburg an der Havel 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
Universitätsklinikum Halle (Saale) Halle Germany
Medizinische Hochschule Hannover Hanover Germany
Universitätsklinikum Heidelberg Heidelberg Germany
Universitätsklinikum Jena Jena Germany
Universitätsmedizin Greifswald / Klinikum Karlsburg Karlsburg Germany
Universitätsklinikum Schleswig-Holstein Kiel Germany
Bundeswehrzentralkrankenhaus Koblenz Koblenz 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

+ 3 more sites — see the full list on the official registry below.

More Universitätsklinikum Hamburg-Eppendorf trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03112980 on ClinicalTrials.gov ↗ ← All trials in Germany