GECT-DZHK28

A first-in-human feasibility study to evaluate the safety (and short term effectiveness) of the autologous GrOwnValve transcatheter pulmonary heart valve (GECT-DZHK28)

In the GECT-DZHK28 study of the German Center for Cardiovascular Research, scientists are ivestigating a heart valve replacement made of the patient's own tissue in humans, which is unique worldwide according to the current state of knowledge. The aim is to obtain safe implants that will last a lifetime, if possible. The heart valves currently in use either become dysfunctional over time due to calcification or require permanent intake of medication. In children, it is also problematic that those artificial heart valves do not grow. Using the patient's own tissue from the pericardium, the scientists use 3D data from MRI or CT to form a new, patient-specific valve for the patient. In sheep, they have already achieved excellent long-term results with such an autologous pulmonary valve implant. Now, for the first time, they are investigating in humans whether such a tissue-engineered heart valve can be used safely. Seven young adults with a congenital pulmonary valve defect will participate in this safety study. The patients will be examined every three months during the first year after the valve implant has been inserted using a catheter. In total, the follow-up period will last five years. If the study is successful, the study management under the direction of PD Dr. Boris Schmitt from the German Heart Center Berlin plans a follow-up study in which ten children will also receive a heart valve made of their own tissue. Heart valves that grow with the patient are particularly relevant for children with a narrowed pulmonary valve, a common congenital heart defect, as these children get surgery every four to five years on average to receive a new valve.

Publications

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Principal Investigators

Principal investigator: Boris Schmitt (Berlin)

Press releases and news

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