Feasibility Study to Evaluate the Safety of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve
Key facts
- Where
- Berlin, GermanySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05809856, who can take part
Where in Germany
- Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Deutsches Herzzentrum der CharitéBerlin, GermanyContact: Svenja Broschag, MScTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Charite University, Berlin, Germany
- Trial code
- NCT05809856
- Record updated
- 29 September 2025
- Original description
Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.Read full original descriptionShow less
A First-in-Human Feasibility Study to Evaluate the Safety (and Short Term Effectiveness) of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve [GECT]
Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.
Inclusion: Age ≥ 18 years; Sufficient appropriate tissue (preferably: Pericardium for pericardiectomy via thoracoscopy or thoracotomy, or sternotomy; other options are fascia lata, rectus fascia, peritoneum or diaphragm); 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); Written informed consent provided by study subjects obtained before any research-related test is performed.
Exclusion: Active endocarditis or myocarditis or within 3 months before the screening date; Requires emergency surgery; Recipient of transplanted organs or currently an organ transplant candidate; 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; Adult subject is an illicit drug user, alcohol abuser, or unable to give informed consent; 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; Pulmonary hypertension; Connective tissue disorders; Coronary artery disease; Immunosuppressive disease; Acute myocardial infarction within 30 days of the screening date; 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; 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; Patients unwilling or unable to provide written informed consent or comply with follow-up requirements; 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; Subject is institutionalized by court order or by order of authority (e.g. prisoner, untreated psychiatry; limited compliance); Subjects who are dependent on the sponsor or investigators.