Actively Recruiting
A First-in-Human Study to Evaluate Safety and Short-Term Effectiveness 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
47 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
This research aims to evaluate the clinical safety of a new pediatric heart valve called the GrOwnValve, designed to treat defective or diseased pulmonary heart valves that do not heal naturally. The study addresses a critical need for valve replacements with regenerative and growth potential for children and adults at risk of progressive heart failure and death. The trial is a first-in-human, non-randomized, single-center investigation involving at least 7 adult participants aged 18 years and older. The GrOwnValve is made from the patient's own tissue and implanted using a minimally invasive transcatheter technique into patients with severe pulmonary valve insufficiency and right ventricular enlargement. The valve is prepared using a novel preservation method to maintain cell vitality and regenerative capacity. This device aims to overcome current limitations by adapting to patient growth and may become a new standard of care. The valve is implanted during a single procedure without a control group, but outcomes will be compared to existing bioprosthetic valves. Participants will undergo evaluations including heart imaging and clinical assessments before and after valve implantation. Researchers will monitor safety outcomes such as death, major bleeding, reoperations, device complications, heart rhythm, and valve function over up to five years. Secondary measures include hospital stay length, ventilation time, arrhythmias, and rehospitalizations. The total participation may last several years with follow-up visits to assess valve performance, heart function, and patient well-being.
CONDITIONS
Brief Title
Feasibility Study to Evaluate the Safety of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Sufficient appropriate tissue available for valve preparation, preferably pericardium or other suitable tissues
- For NYHA class II, III, or IV: Moderate to severe pulmonary regurgitation or mean systolic gradient across pulmonary valve or right ventricular outflow tract of 35 mmHg or higher
- For NYHA class I: Severe pulmonary regurgitation with right ventricular dilatation or dysfunction or mean systolic gradient of 40 mmHg or higher
- Right ventricular ejection fraction less than 40%
- Right ventricular end-diastolic volume greater than 150 ml/m2 body surface area
- Written informed consent provided before any research-related tests
You will not qualify if you...
- Active endocarditis or myocarditis within 3 months before screening
- Unable or unwilling to provide informed consent or comply with follow-up
- Obstruction of central veins preventing valve delivery system access
- Emergency surgery required
- Organ transplant recipient or candidate
- Pulmonary hypertension
- Connective tissue disorders
- Coronary artery disease
- Immunosuppressive disease
- Life expectancy less than 6 months
- Fertile females unable to use adequate contraception
- Pregnant or breastfeeding females
- Acute myocardial infarction within 30 days before screening
- Recent stroke or transient ischemic attack within 6 months
- Hemodynamic or respiratory instability requiring support within 30 days
- Severe left ventricular dysfunction or intracardiac mass
- Renal insufficiency with high creatinine levels
- Blood disorders with bleeding risk
- Illicit drug use or alcohol abuse
- Institutionalized by court order or limited compliance
- Major progressive non-cardiac disease with life expectancy under 6 months
- Unable to comply with study procedures and visits
- Dependence on sponsor or investigators
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day plus hospital stay up to 30 days
Participants undergo implantation of the autologous GrOwnValve via a minimal-invasive transcatheter technique for pulmonary valve replacement.
1 procedure visit and several post-procedure hospital visits until discharge
Duration - Up to 5 years
Participants are monitored for safety and valve performance, including complications and heart function, for up to 5 years after valve implantation.
Multiple follow-up visits over 5 years
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
Research Team
B
Boris Schmitt, Dr.
F
Frank Edelmann, Prof. Dr.
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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