functional single ventricle physiology functional single left ventricle functional single right ventricle functional single biventricle MedDRA version: 14.0 Level: LLT Classification code 10040729 Term: Single ventricle System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Product Name: Autologous Tissue-Engineered Vascular Graft
Product Code: SCRM001_TEVG
Pharmaceutical Form: Implant
Sponsors
University of Zurich
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Functional single ventricle physiology (functional single left ventricle, functional single right ventricle, functional single biventricle) - Male or female - Age: 2 - 6 years - Parental / legal guardian’s consent on behalf of the minor subject Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pulmonary artery pressure (PAP) > 15 mm Hg as excluded by angiography/cardiac catheter - Pulmonary vascular resistance (PVR) >3 Wood units as excluded by angiography/cardiac catheter - Moderate or severe atrioventricular (AV) valve regurgitation requiring correction, as determined by echocardiography and / or angiography - Moderate or severe outflow valve regurgitation requiring correction as determined by echocardiography and / or angiography - Outflow tract (aortic arch and isthmus) obstruction as excluded by a) a residual outflow gradient of = 20mm Hg or b) requirement of corrective surgery as determined by angiography/cardiac catheter - All arrhythmia other than normal sinus rhythm as determined by ECG and / or at the investigator’s discretion - Renal dysfunction as excluded by serum creatinin > ULN and / or urea >ULN and / or at the investigator’s discretion - Hepatic dysfunction as excluded by ALT >ULN, AST > ULN, GGT > ULN and / or at the investigator’s discretion - Coagulation disorders as defined by INR outside its normal value, PTT >ULN and Fibrinogen <LLN and / or at the investigator’s discretion - Transcutaneous O2 saturation < 65% or at the investigator’s discretion - Immunodeficiency (ies) / Immune-syndromes - Trisomia 21 - Asplenia as excluded by abdominal ultrasound - Heterotaxia as excluded by abdominal ultrasound - HIV-infection - Syphillis (Treponema pallidum) - Hepatitis-B and /or –C virus infection - Unwillingness of Parental / legal guardian’s to give consent - Contraindications on ethical grounds - Treatment with other investigational products - Known or suspected non-compliance, drug or alcohol abuse of the parents / legal guardian - Inability of the parents / legal guardians to follow the procedures of the study, e.g. due to language problems - Participation of the patient in another study within 30 days preceding and during the present study - Previous enrollment of the patient into the current study - Enrollment of the investigator’s family members, employees and other dependent persons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the safety of the TEVG as defined by 'number of patients with graft related post-operative complications' requiring surgery or leading to death within the first 6 months after TEVG implantation;Secondary Objective: Evaluation of the efficacy of the implated TEVG, analysing the incidence of: - Loss of functionality of the TEVG requiring surgery - Medical condition related to TEVG requiring surgery withing 6, 12, 24 and 36 months after TEVG implantation Evaluation of the long-term safety of the implanted TEVG, as defined by 'number of patients with graft related post-operative complications' within 12, 24 and 36 months after TEVG implantation Evaluation of the biological growth in diameter of the TEVG within 12, 24 and 36 months after TEVG implantation;Primary end point(s): This primary study endpoint is the safety of the TEVG after 6 months of postimplantation. This endpoint will be evaluated by the number of patients with graft related postoperative complications requiring surgery or leading to death within the first 6 months of post-implantation.;Timepoint(s) of evaluation of this end point: 6 month after TEVG implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: Secondary study endpoints will address the long-term safety of the implanted TEVG, as defined by ‘number of patients with graft related post-operative complications’ within the first 12, 24, 36 months after TEVG implantation by assessing all SAEs / graft related SAEs and cardiovascular related other relevant AEs. Evaluation of the efficacy of the implanted TEVG, analysing the incidence of Loss of functionality of the TEVG requiring surgery Medical condition related to TEVG requiring surgery within 6, 12, 24 and 36 months after TEVG implantation. Evaluation of biological growth: Evaluation of the biological growth of the TEVG will be determined by echocardiographic measurements of the diameter of the TEVG until 36 months after surgery.;Timepoint(s) of evaluation of this end point: 6, 12, 24 and 36 months after TEVG implantation | — |
Countries
Germany
Contacts
Public ContactZentrum für Regenerative Medizin
Universitiy of Zurich
Outcome results
None listed