An interventional study of GrOwnValve - novel heart valve replacement approach in Pulmonary Valve Insufficiency, sponsored by Charite University, Berlin, Germany. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment
Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.
Defective or diseased pulmonary heart valves do not recover. If left untreated, pediatric and adult patients alike, face serious risks of progressive heart failure and death. Due to the insufficient care of children with heart valve defects, the valve replacement with regenerative, remodeling, and growth potential remains an unmet medical need. Therefore, the first pediatric heart valve (GrOwnValve) was developed to overcome the current limitations, which should offer regenerative potential that adapts to the somatic growth of the child. The study aims to investigate the safety and provide the first initial efficacy estimates of the transcatheter implantable GrOwnValve. This first prospective, non-randomized, single center trial in 7 study subjects (≥ 18 years of age) should be conducted to assess the devices safety for clinical application.
The novel interdisciplinary solution approach is based on the combination of individualized 3D modeling, viable autologous tissue (contrary to all other prosthetic heart valves on the market), and preservation of the regenerative capacity of the valve replacement by maintaining the vitality of heart valve cells and tissue through the application of a novel crosslinker in the tissue preparation process. The GrOwnValve prothesis has the potential to be the first durable and regenerative heart valve for adults. Fabrication is performed on-demand in the operating room. The trial should be the first clinical investigation assessing this novel heart valve replacement approach. We are aiming for the GrOwnValve to be the standard of care, replacing current solutions.
31 studies on the registry are indexed under Pulmonary Valve Insufficiency; 8 are open to participants now.
This study's planned enrollment of 7 is below the median of 60 across 21 interventional studies indexed under Pulmonary Valve Insufficiency.
Browse Pulmonary Valve Insufficiency studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Any of the following by transthoracic echocardiography and/or Cardiac Magnet Resonance Imaging:
Exclusion Criteria:
Implantation of autologous GrOwnValve via minimal-invasive transcatheter technique into patients with high-grade pulmonary valve insufficiency and right ventricular dilatation.
Device: GrOwnValve - novel heart valve replacement approach
The 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)
Time frame: Up to 5 Years Follow-Up
Major bleeding
Assessment if device-related major bleeding has occured by laboratory + echo + CT
Time frame: Up to 1 Year Follow-Up
Reoperation
Questioning if device-related re-operation occured
Time frame: Up to 5 Years Follow-Up
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
Time frame: Up to 5 Years Follow-Up
Oxygen supply
Measurement tool: Spiroergometry 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
Time frame: Up to 5 Years Follow-Up
Valve opening and closure behavior
Measurement tool: Echocardiography + Magnetic resonance imaging Parameter: 1.) blood flow velocity / stenosis, 2.) stiff leaflet, 3.) valve opening area Decision rule: blood flow velocity \>4 m/s, abnormal or no leaflet motion when compared to neighboring leaflets, \> 0.70 for 17 diameter, \> 0.85 for 19, \> 1.05 for 21, \> 1.25 for 23, \> 1.45 for 25, \> 1.70 for 27, 1.95 for 29, and 2.25 for 31 mm annulus diameter
Time frame: Up to 5 Years Follow-Up
Valve closure behavior
Measurement tool: Echocardiography + Magnetic resonance imaging Parameter: 1.) vena contracta, 2.) Proximal Isovelocity Surface Area (PISA) radius, 3.) Effective regurgitation orifice area (EROA=2π\*r2\*Va/Vmax), (iv) sagging leaflet Decision rule: 1.) less than or equal to 15% of the diameter of PA/stent at a Nyquist limit of 0.5-0.6 m/s, frame rate \>20/sec, gain adjusted, sector small, 2.) equal or minor to 4 mm at a Nyquist limit of 0.2-0.4 m/s, frame rate \>20/sec, gain adjusted, variance off, sector small, 3.) \< or equal to 3% of the total cross-sectional area of the valve, 4.) n.a
Time frame: Up to 5 Years Follow-Up
Heart rhythm
Assessment if new or higher grade of cardiac arrhythmia occured, i.e. newly ventricular extra systoly
Time frame: Up to 5 Years Follow-Up
Position and condition of the stent and structures
Measurement tool: Echocardiography + Magnetic resonance imaging + computed tomography Parameter: 1.) GrOwnValve annulus, 2.) no broken struts of the valve stent Decision rule: 1.) +/- 1.5 mm from the native pulmonary valve annulus, 2.) n.a.
Time frame: Up to 1 Year Follow-Up
Blood flow
Assessment of backflow and volume of blood by echo + MRI
Time frame: Up to 1 Year Follow-Up
Availability of pericardium or other tissue for preparation of autologous pulmonary valve graft
Visual assessment of pericardium
Time frame: Procedure (intra-operatively)
Post-procedure length of stay
Post-procedure hospital stay in days.
Time frame: Up to day of discharge ( ≤ 30 days)
Ventilation time
Timepoints: Procedure Assessment: How long was the ventilation time for each patient within the allocation?
Time frame: Procedure (intra-operatively)
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?
Time frame: Up to 3 months Follow-Up
(Re-)Hospitalization
Timepoints: Discharge, Visit 1, Visit 2, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8 Assessment: Is a (Re-)Hospitalization necessary due to procedure- or device-related complications?
Time frame: Up to 60 months (5 years) Follow-Up
Comparison of pericardiectomy (if applicable) via thoracoscopy vs. thoracotomy
Timepoints: Procedure Assessment: How was the pericardiectomy conducted, via thoracoscopy or thoracotomy
Time frame: Procedure (intra-operatively)
Procedure-related death, major bleeding, reoperation, and other complications.
Assessment of the GrOwnValve procedure's safety. Therefore, procedure-related death, major bleeding, reoperation, and other complications will be documented combined and individually for 6 months. Whenever the procedure evaluates as "not safe", the reasons will be documented.
Time frame: Follow-Up for 6 months
Plan to share: No
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Pulmonary Valve Insufficiency→
Charite University, Berlin, Germany