Clinical trial NCT02794584: Hybrid Closure of Congenital Heart Disease
Official title: Precision Assessment of Perioperative Effectiveness and Safety of Transthoracic Minimally Invasive Hybrid Closure for Pediatric Ventricular Septal Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Ventricular Septal Defects
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2016-06-09
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of perimembranous ventricular septal defect, muscular ventricular septal defect, doubly committed subarterial VSD by transesophageal echocardiogram (TEE) with VSD size 5-12mm;
* no significant aortic insufficiency or aortic valve prolapse.

Exclusion Criteria:

* confirmed pulmonary hypertension (systolic pulmonary arterial pressure \>75mmHg or pulmonary vascular resistance \>8.0 Wood U/m2);
* more than mild degree of aortic regurgitation and obvious aortic valve prolapse;
* preoperative congestive heart failure;
* other coexisting cardiac anomalies;
* infective endocarditis.

Primary outcomes:
measure: Myocardial injury as measured by cardiac troponin I serum
timeFrame: 7 days postoperatively after cardiac surgery
measure: Respiratory dysfunction as measured by PaO2
timeFrame: 7 days postoperatively after cardiac surgery
Secondary outcomes:
measure: All cause mortality
timeFrame: 7 days postoperatively after cardiac surgery
Other outcomes:
measure: Number of participants with right bundle branch block assessed by ECG
timeFrame: 7 days postoperatively after cardiac surgery
measure: Left ventricular ejection fractions
timeFrame: 7 days postoperatively after cardiac surgery
measure: Extravascular lung water index
timeFrame: 7 days postoperatively after cardiac surgery
Locations:
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Hai-tao Gu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.