drugset / Trial / NCT02794584
Hybrid Closure of Congenital Heart Disease
RandomizedParallel-groupDouble-blindTreatment
Summary
Ventricular septal defect (VSD) is one of the most common pediatric congenital malformations. In recent years, in view of the rapid rise of transthoracic minimally invasive hybrid closure for pediatric VSD in the clinical practice, precision assessment of perioperative its effectiveness and safety has already become an important issue that must be solved. On the basis of echocardiography, integrating with characteristics associated critical care, the investigators focus on precision assessment of perioperative effectiveness and safety of transthoracic hybrid closure for pediatric VSD, compared with conventional surgical sternotomy repair with cardiopulmonary bypass (CPB).
Timeline
- Start
- 2011-01
- Primary completion
- 2016-12
- Completion
- 2016-12
Publications
- Background Amin Z, Danford DA, Lof J, Duncan KF, Froemming S. Intraoperative device closure of perimembranous ventricular septal defects without cardiopulmonary bypass: preliminary results with the perventricular technique. J Thorac Cardiovasc Surg. 2004 Jan;127(1):234-41. doi: 10.1016/j.jtcvs.2003.08.023.
- Liu H, Lu FX, Zhou J, Yan F, Qian SC, Li XY, Zheng SQ, Chen JQ, Zhong JS, Feng QL, Ding T, Fan J, Gu HT, Liu XC. Minimally invasive perventricular versus open surgical ventricular septal defect closure in infants and children: a randomised clinical trial. Heart. 2018 Dec;104(24):2035-2043. doi: 10.1136/heartjnl-2017-312793. Epub 2018 Jun 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Isoflurane | Other / unclassified | 0.7 % | Inhaled |
| Comparator | Isoflurane | Other / unclassified | 0.8 % | Inhaled |
| Comparator | Sufentanil | Other / unclassified | — | Other |