Evaluating a new heart valve for pulmonary valve insufficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.