Hybrid Closure of Congenital Heart Disease

Study Overview
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Brief Summary
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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).

Official Title
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Precision Assessment of Perioperative Effectiveness and Safety of Transthoracic Minimally Invasive Hybrid Closure for Pediatric Ventricular Septal Defects

Conditions
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Pediatric Ventricular Septal Defects

Intervention / Treatment
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* Drug: sufentanil anesthesia
* Procedure: Hybrid closure
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Off-pump hybrid closure<br>Hybrid closure is that a periventricular technique uses an occluding device to closure ventricular septal defects of patients through the delivery system by transthoracic minimally invasive small incision without cardiopulmonary bypass. | Drug: sufentanil anesthesia<br>* Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. During extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations.<br>* Other names: Sufentanil, Sufenta, (R-30730);Procedure: Hybrid closure<br>* Hybrid closure of ventricular septal defects through the delivery system without cardiopulmonary bypass by transthoracic minimally invasive small incision.<br>* Other names: TTMI: Transthoracic Minimally Invasive;|
| Placebo Comparator: Control<br>Control group: Conventional closure of ventricular septal defects was aided with cardiopulmonary bypass. | Drug: sufentanil anesthesia<br>* Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. During extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations.<br>* Other names: Sufentanil, Sufenta, (R-30730);Procedure: Control<br>* Surgical closure of ventricular septal defects with cardiopulmonary bypass by routine open thoracotomy.<br>* Other names: CPB: cardiopulmonary bypass;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial injury as measured by cardiac troponin I serum |  | 7 days postoperatively after cardiac surgery | 
| Respiratory dysfunction as measured by PaO2 |  | 7 days postoperatively after cardiac surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 7 days postoperatively after cardiac surgery |