Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT05809856

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

Led by Charite University, Berlin, Germany · Updated on 2025-09-29

7

Participants Needed

1

Research Sites

419 weeks

Total Duration

On this page

Sponsors

C

Charite University, Berlin, Germany

Lead Sponsor

G

GrOwnValve GmbH

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Sufficient suitable tissue available (preferably pericardium, fascia lata, rectus fascia, peritoneum, or diaphragm)
  • Moderate (3+) or severe (4+) pulmonary regurgitation and/or mean systolic gradient across pulmonary valve or right ventricular outflow tract (RVOT) ≥ 35 mmHg for NYHA class II-IV patients
  • Severe (4+) pulmonary regurgitation with right ventricular dilatation or dysfunction and/or mean systolic gradient ≥ 40 mmHg for NYHA class I patients
  • Right ventricular ejection fraction below 40%
  • Right ventricular end-diastolic volume greater than 150 ml/m2 body surface area
  • Written informed consent provided before any research-related test
Not Eligible

You will not qualify if you...

  • Active endocarditis or myocarditis within 3 months before screening
  • Unwilling or unable to provide informed consent or comply with follow-up
  • Obstruction of central veins preventing transvenous device delivery
  • Requires emergency surgery
  • Recipient of transplanted organs or transplant candidate
  • Pulmonary hypertension
  • Connective tissue disorders
  • Coronary artery disease
  • Immunosuppressive disease
  • Estimated survival less than 6 months
  • Fertile females unable to use adequate contraception
  • Pregnant or breastfeeding females
  • Acute myocardial infarction within 30 days before screening
  • Stroke or transient ischemic attack within 6 months before screening
  • Hemodynamic or respiratory instability requiring circulatory or mechanical support within 30 days before screening
  • Severe left ventricular dysfunction (ejection fraction ≤ 20%) or evidence of intracardiac mass or thrombus
  • Renal insufficiency with creatinine level ≥ 2.5 mg/dl within 60 days before screening
  • Leukopenia, anemia, or thrombocytopenia with bleeding history within 60 days before screening
  • Illicit drug use, alcohol abuse, or inability to consent
  • Institutionalized by court or authority order
  • Major or progressive non-cardiac disease with life expectancy less than 6 months
  • Inability to comply with study procedures and follow-up
  • Dependence on sponsor or investigators

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

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

Berlin, State of Berlin, Germany, 13353

Actively Recruiting

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Research Team

B

Boris Schmitt, Dr.

CONTACT

F

Frank Edelmann, Prof. Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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