Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection

Although significant progress has been made in recent years in the field of congenital heart disease treatment, a substantial unmet clinical need remains for implantable materials/devices such as vascular grafts and heart valves with improved long-term performance and reduced device-related complications.

To address these limitations new generation of biodegradable polymers using recent advances in supramolecular chemistry have been developed to create highly porous vascular grafts allowing efficient cell infiltration following by gradual replacement of the polymer material with the patient's own native-like vascular tissue resulting in full functional restoration. In addition to the ability of reducing postoperative graft-related complications such types of implants have a potential to grow to adapt to the overall body growth and therefore may represent a completely new modality for the treatment of congenital heart disease. In contrast to today's situation with synthetic non-absorbable vascular grafts considered as a "standard of care", where the pediatric patients have to be re-operated several times to adjust the prosthesis size to the somatic growth of the child associated with substantial morbidity and mortality and requiring prolonged anticoagulation treatment, a biodegradable polymer implant could represent a "one-time solution".

Inclusion criteria

• Patient requiring EC-TCPC
• Male or Female
• Aged ≥ 2 years

Exclusion criteria

• Pulmonary artery pressure (PAP) > 15 mm Hg as excluded by angiography/cardiac catheterization
• Pulmonary vascular resistance (PVR) >3 Wood units as excluded by angiography/cardiac catheterization
• 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 residual outflow gradient of ≥ 20mm Hg or
• requirement of corrective surgery
• as determined by echocardiography and/ or angiography
• All arrhythmias as determined by ECG and/or at the investigator's discretion
• Renal dysfunction as excluded by serum creatinine > 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% and/or at the investigator's discretion
• Immunodeficiency
• Trisomia 21
• Asplenia as determined by abdominal ultrasound
• Heterotaxia as determined by abdominal ultrasound
• HIV-infection
• Syphilis (Treponema pallidum)
• Hepatitis-B and/or -C virus infection
• Unwillingness of Parental/legal guardian 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 guardian 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