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

NCT05809856 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-09-29

No results posted yet for this study

Summary

Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.

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).

Sponsors & Collaborators

  • GrOwnValve GmbH

    collaborator UNKNOWN

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Boris Schmitt, Dr. · Charité UNiveristätsmedizin Berlin, Deutsches Herzzentreum der Charité

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-18
Primary Completion
2031-01-31
Completion
2031-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05809856 on ClinicalTrials.gov