DEDICATE-DZHK6


Study information
DEDICATE-DZHK6

Recruiting status

Recruiting ongoing

Recruitment start

05/2017

Patients

1359

1403

Clinical Trials Registration

NCT03112980

Category

Guideline relevant study

DZHK Funding

EUR 3.904.488,61

Links

https://dedicate.dzhk.de/

Operative contact
Main study centre - Moritz Seiffert, MD
dedicate@dzhk.de

Studienzentren/Kontakt (PDF)

Randomized Trial of TAVI versus SAVR in Patients with Symptomatic Severe Aortic Valve Stenosis and Intermediate Risk of Mortality (DEDICATE-DZHK6)

In the case of severe aortic valve stenosis, the valve must be replaced by an artificial one. The industry studies DEDICATE study examines the more suitable method for patients with moderate to low surgical risk (STS score 3 to 6). There are two methods: the patient’s thorax is opened surgically and an artificial valve is implanted; or a new valve is advanced through a femoral artery up to the heart using a catheter (TAVI method).

Only patients who are eligible for both methods may participate in the study. They will be assigned randomly to two groups and their survival rate will be determined over five years. In comparison to other studies, DEDICATE is distinctive in another way: for the first time, not only TAVI valves of one manufacturer will be compared to the surgical procedure, but the physician can choose the valve according to accuracy of fit and size from various models and manufacturers. The same applies to the surgical valves.

All partner hospitals of the DZHK and other leading hospitals in Germany are participating in the study. Currently, health insurance companies usually only reimburse TAVI, which is almost twice as expensive, for patients with a high surgical risk or if someone is inoperable. the study’s outcomes will provide the chance for more objectivity and procedural safety for patients, physicians and health insurance companies.

Publications

The Dedicate Trial: An Independent All-Comers Trial of Transcatheter Aortic Valve Implantation Vs. Surgical Aortic Valve Replacement in Patients at Low to Intermediate Operative Risk Is Recruiting Patients. Seiffert, M. et al. J. European heart journal 40, 331-333, (2019).

More publications here

Principal Investigators

Prof. Dr. Stefan Blankenberg
Universitätsklinikum Hamburg-Eppendorf (UKE)
PD Dr. Moritz Seiffert
Universitätsklinikum Hamburg-Eppendorf

Press releases and news

DZHK study: Catheter or surgery? Clinical study on heart valve replacement begins

One of the most common acquired heart diseases in the over 75’s is aortic valve stenosis. Normally,...

Study recruitment is available in these cities

The map only displays recruitment locations within Germany.