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

Recruiting now · Not applicable

Conditions studied: Pulmonary Valve Insufficiency

In brief

Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.

Key facts

Study ID

NCT05809856

Run by

Charite University, Berlin, Germany

People needed

7

Starts

2023-12-18

Expected to finish

2031-12-31

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Deutsches Herzzentrum der Charité — Berlin, State of Berlin, Germany (enrolling)

Full record on ClinicalTrials.gov

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