Q23.4
Conditions
Interventions
Group 1: Retrospectively, clinical data on complication-free survival of neonates who received a self-expanding ductus arteriosus stent according to the Giessen Hybrid Approach will be collected.
Sponsors
optimed Medizinische Instrumente GmbH
Eligibility
Sex/Gender
All
Age
0 Years to 5 Years
Inclusion criteria
Inclusion criteria: 1. Patients treated with the “Giessen Hybrid” approach 2. Patient underwent the following procedure: “Giessen Hybrid” Approach Stage I (including: surgical bilateral pulmonary artery banding (bPAB) and implantation of the SSF-DS in the PDA)
Exclusion criteria
Exclusion criteria: 1. Lost to follow-up during Interstage I 2. Unavailable outcome data at planned assessment time points 3. Incomplete data for gender, disease presentation, and reason(s) for change of medication / intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival after completed Stage I (30-day mortality) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Overall survival during Interstage I - Complication-free survival during Interstage I - Overall survival during Comprehensive Stage II surgery (30-day mortality) - Overall survival after Comprehensive Stage II surgery (till Fontan surgery) - Complication-free survival after Comprehensive Stage II surgery (till Fontan surgery) - Overall survival during Fontan surgery Stage III - Overall survival after Fontan surgery Stage III - Complication-free survival after Fontan surgery Stage III - Angiographic measurements of the Ductus and the stent before, during and after Giessen Hybrid Approach surgery (Stage I) (at least 10 data sets, Vessel diameter of ductus arteriosus, Bending radius of stent, Bending length of stent) | — |
Countries
Germany
Contacts
Public ContactGunter Kerst
Klinik für KinderkardiologieSchwerpunkt interventionelle ElektrophysiologieKinderherzzentrum Aachen
Outcome results
None listed