Hybrid Closure of Congenital Heart Disease

Nanjing Medical University

Status: Completed

Conditions: Pediatric Ventricular Septal Defects

Treatments: Procedure: Control; Drug: sufentanil anesthesia; Procedure: Hybrid closure

Study type: Interventional

Funder types: Other

Identifiers

NCT02794584

CHD-Nanjing

Details and patient eligibility

About

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).

Enrollment: 200 patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Off-pump hybrid closure

Active Comparator group

Description:

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.

Treatment:

Procedure: Hybrid closure

Drug: sufentanil anesthesia

Control

Placebo Comparator group

Description:

Control group: Conventional closure of ventricular septal defects was aided with cardiopulmonary bypass.

Treatment:

Procedure: Control

Drug: sufentanil anesthesia