7
Participants
Start Date
December 18, 2023
Primary Completion Date
January 31, 2031
Study Completion Date
December 31, 2031
GrOwnValve - novel heart valve replacement approach
The autologous GrOwnValve is implanted into a stent before it is implanted via minimal-invasive transcatheter technique into the patients with high-grade pulmonary valve insufficiency and right ventricular dilatation. Control intervention/Reference test: Since the study is designed for investigating the safety of the procedure, there will not be a control group. However, the outcomes will be compared as a non-inferiority analysis with the standard of current medical care (Edwards SAPIEN 3 or Medtronic's Melody, both bioprosthetic transcatheter pulmonary valves).
RECRUITING
Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Deutsches Herzzentrum der Charité, Berlin
GrOwnValve GmbH
UNKNOWN
Charite University, Berlin, Germany
OTHER