Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.
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)
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
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
Single group
GrOwnValve - novel heart valve replacement approach
DeviceThe autologous GrOwnValve is implanted into a stent before it is implanted via minimal-invasive transcatheter technique into the patients with high-grade pulmonary valve insufficiency and right ventricular dilatation. Control intervention/Reference test: Since the study is designed for investigating the safety of the procedure, there will not be a control group. However, the outcomes will be compared as a non-inferiority analysis with the standard of current medical care (Edwards SAPIEN 3 or Medtronic's Melody, both bioprosthetic transcatheter pulmonary valves).
Death
(valve-related, sudden, cardiac, and all-cause death)
Major bleeding
Assessment if device-related major bleeding has occured by laboratory + echo + CT
Reoperation
Questioning if device-related re-operation occured
Acute device-related complications
Measurement tool: Spiroergometry o Parameters: cardiac rhythm, load duration, reason for termination, Heart rate at rest, blood pressure, maximum load level, VE/VCO2, PetCO2, VE/VCO2 slope, VO2, Respiratory rate, VD/VT, SpO2, RER, Borg score, FEV1, FVC
Availability of pericardium or other tissue for preparation of autologous pulmonary valve graft
Visual assessment of pericardium
Post-procedure length of stay
Post-procedure hospital stay in days.
Ventilation time
Timepoints: Procedure Assessment: How long was the ventilation time for each patient within the allocation?
Freedom from conduction disturbances and arrhythmias need for permanent pacemaker implantation
Timepoints: Procedure + Discharge + Visit 1 Assessment: Is the implantation of a permanent pacemaker necessary due to disturbances or arrhythmias?
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Charite University, Berlin, Germany
Lead sponsor
GrOwnValve GmbH
Collaborator
