Hybrid Closure of Congenital Heart Disease

Not Applicable

Completed

• Conditions: Pediatric Ventricular Septal Defects
• Interventions: Drug: sufentanil anesthesia; Procedure: Hybrid closure; Procedure: Control

• Registration Number: NCT02794584
• Lead Sponsor: Nanjing Medical University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-06-04
• Study First Posted: 2016-06-09
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-25
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Off-pump hybrid closure	sufentanil anesthesia	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.
Control	sufentanil anesthesia	Control group: Conventional closure of ventricular septal defects was aided with cardiopulmonary bypass.
Off-pump hybrid closure	Hybrid closure	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.
Control	Control	Control group: Conventional closure of ventricular septal defects was aided with cardiopulmonary bypass.

Primary Outcome Measures

Name	Time	Method
Respiratory dysfunction as measured by PaO2	7 days postoperatively after cardiac surgery
Myocardial injury as measured by cardiac troponin I serum	7 days postoperatively after cardiac surgery

Secondary Outcome Measures

Name	Time	Method
All cause mortality	7 days postoperatively after cardiac surgery