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DEDICATE-DZHK6

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.

Principal Investigators

Principal investigator: Stefan Blankenberg (Hamburg), Co-PI: Moritz Seiffert (Hamburg)

Medical institution

Medizinische Fakultät der Universität Hamburg

Keywords

Recruitment start

05/2017

Patients (planned)

1403

Patients (recruited)

1421 (completed)

ClinicalTrials.gov

NCT03112980