Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect

A Randomized Controlled Trial of Minimally Invasive Transthoracic Device Closure in the Treatment of Patients With Perimembranous Ventricular Septal Defect

The purpose of this study is to evaluate the efficacy and safety of minimally invasive transthoracic device closure of ventricular septal defect. This is a multi-center randomized controlled trial. Because of the characteristics of this surgical clinical trials, surgeons, ultrasonic department doctors, anesthesiologists, operating room nurses and intensive care unit nurses are all need to be informed. Therefore the results of this trial need to be system evaluated through objective methods to reduce bias.

Several examinations need to be done in all the patients, including X-ray, electrocardiogram, echocardiogram, blood routine examination, liver and kidney function, electrolytes, coagulation function and infectious index checks. And they will be divided into two groups after they have obtained informed consent: surgical group (50 cases); closure group (50 cases). If the closure failed, the patients in closure group will be converted to surgical repair with cardiopulmonary bypass .

Recheck X-ray, electrocardiogram, echocardiogram, blood routine examination, liver and kidney function and electrolytes need to be done in all the patients two days after operation. The patients were followed up by X-ray, electrocardiogram, echocardiogram at the first month, third month, sixth month and the first year.

Inclusion Criteria:

• Age≥3 months
• Patients with isolated perimembranous ventricular septal defect with hemodynamic abnormalities. Diameter of the defect is greater than 3mm, and less than 10mm

Exclusion Criteria:

• Para adverse ventricular septal defect
• Muscular ventricular septal defect, subpulmonic ventricular septal defect and septal leaflet posterior atrioventricular canal ventricular septal defect
• Patients with severe pulmonary hypertension in right-to-left shunt
• Patients with obvious aortic valve prolapse, with moderate or severe aortic regurgitation
• Infective endocarditis, and heart cavity neoplasm
• Patients with other cardiovascular malformations, which require surgery with cardiopulmonary bypass to correct at the same period