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

Trial 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.

ClinicalTrials.gov NCT05809856