Feasibility Study to Evaluate the Safety of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve

NARecruitingINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

December 18, 2023

Primary Completion Date

January 31, 2031

Study Completion Date

December 31, 2031

Conditions
Pulmonary Valve Insufficiency
Interventions
DEVICE

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).

Trial Locations (1)

13353

RECRUITING

Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Deutsches Herzzentrum der Charité, Berlin

All Listed Sponsors
collaborator

GrOwnValve GmbH

UNKNOWN

lead

Charite University, Berlin, Germany

OTHER