Evaluating a new heart valve for pulmonary valve insufficiency
A First-in-Human Feasibility Study to Evaluate the Safety (and Short Term Effectiveness) of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve [GECT]
This study is testing a new heart valve designed for kids and young adults with pulmonary valve insufficiency to see if it is safe and works well as they grow.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 7 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin, State of Berlin) |
| Trial ID | NCT05809856 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety of the GrOwnValve, a novel pediatric heart valve designed to address pulmonary valve insufficiency. The valve aims to provide regenerative potential, adapting to the growth of children and adults with heart valve defects. The trial will involve a small group of participants (≥ 18 years) and assess the device's safety and initial efficacy through a non-randomized, single-center approach. The GrOwnValve is created using individualized 3D modeling and viable autologous tissue, offering a unique solution to a significant medical need.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with moderate to severe pulmonary regurgitation and intact appropriate tissue for valve implantation.
Not a fit: Patients lacking appropriate tissue for valve replacement or with active endocarditis may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a durable and regenerative heart valve option for patients with pulmonary valve insufficiency.
How similar studies have performed: While this approach is novel, similar studies exploring regenerative heart valves have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Sufficient appropriate tissue (preferably: Pericardium for pericardiectomy via thoracoscopy or thoracotomy, or sternotomy; other options are fascia lata, rectus fascia, peritoneum or diaphragm) 3. Any of the following by transthoracic echocardiography and/or Cardiac Magnet Resonance Imaging: * For patients in New York Heart Association (NYHA) Classification II, III, or IV: Moderate (3+) or severe (4+) pulmonary regurgitation AND/OR mean systolic gradient across PV or RVOT ≥ 35 mmHg * For patients in NYHA Classification I: Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction and/or mean PV or RVOT systolic gradient ≥ 40 mmHg * Right ventricular ejection fraction (RV-EF): \<40%. * Right ventricular end-diastolic volume (RVEDV): \>150 ml/m2 (body surface area) 4. Written informed consent provided by study subjects obtained before any research-related test is performed Exclusion Criteria: * Active endocarditis or myocarditis or within 3 months before the screening date * Patients unwilling or unable to provide written informed consent or comply with follow-up requirements * Obstruction of the central veins (including the superior and inferior vena cava, and bilateral iliac veins) such that the Ensemble-delivery system/ Performer™ - Guiding Sheath/ Extra Large Check-Flo® or GORE® DrySeal Flex + Ballon-in-Ballon-catheter cannot be advanced to the heart via a transvenous approach from either femoral vein or internal jugular * Requires emergency surgery * Recipient of transplanted organs or currently an organ transplant candidate * Pulmonary hypertension * Connective tissue disorders * Coronary artery disease * Immunosuppressive disease * Estimated survival of less than 6 months * Fertile females unable to take adequate contraceptive precautions (PEARL- Index \< 1%) * Females who are pregnant, or are currently breastfeeding an infant * Acute myocardial infarction within 30 days of the screening date * Stroke confirmed by CT, cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months before the screening date * Hemodynamic or respiratory instability requiring inotropic or/and mechanical circulatory support, or mechanical ventilation within 30 days before the screening date * Severe left ventricular systolic dysfunction with ejection fraction ≤ 20% or evidence of an intra-cardiac mass, thrombus, or vegetation assessed by echocardiography before the screening date * Renal insufficiency with creatinine level 2.5 mg/dl within 60 days before the screening date * Leukopenia with WBC \<3.5 x 109/L anemia with Hgb \<10 g/dl, or thrombocytopenia with platelet count \<50x103/l accompanied by a history of bleeding diathesis or coagulopathy within 60 days before the screening date * Adult subject is an illicit drug user, alcohol abuser, or unable to give informed consent * Subject is institutionalized by court order or by order of authority (e.g. prisoner, untreated psychiatry; limited compliance) * Major or progressive non-cardiac disease (liver failure, renal failure, cancer)that has a life expectancy of less than six months Inability to comply with all of the study procedures and follow-up visits * Subjects who are dependent on the sponsor or investigators
Where this trial is running
Berlin, State of Berlin
- Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Deutsches Herzzentrum der Charité — Berlin, State of Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Boris Schmitt, Dr.
- Email: boris.schmitt@charite.de
- Phone: +49 30 4593 2846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.