Pilot study with children suffering from congenital heart defect who need a vascular surgery: Implantation of a living blood vessel that is produced in the laboratory from child's own body tissue.
- Conditions
- functional single ventricle physiologyfunctional single left ventriclefunctional single right ventriclefunctional single biventricleMedDRA version: 14.0Level: LLTClassification code 10040729Term: Single ventricleSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2011-001187-21-DE
- Lead Sponsor
- niversity of Zurich
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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 - 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method