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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
minimally invasive transthoracic device closure
surgical repair with cardiopulmonary bypass
Henan Province People's Hospital
Zhengzhou, Henan, China
RECRUITINGXiangYa Hospital CentralSouth University
Changsha, Hunan, China
RECRUITINGThe First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
RECRUITINGthe success rate of the operation
The definition of a successful operation: shunt disappeared
Time frame: index procedure (day 0)
adverse events
death, cardiac perforation, cardiac tamponade, emerging tricuspid regurgitation, emerging aortic regurgitation, arrhythmias (third-degree atrioventricular block, complete bundle branch block), postoperative residual shunt (refers to the residual shunt, which diameter greater than 2mm or flow rate greater than 3m/s), infective endocarditis, postoperative murmur
Time frame: 12 months
thoracic fluid volume
Time frame: index procedure (day 0)
blood transfusion
Time frame: index procedure (day 0)
operating time
time cost from cut the skin to complete closure of the sternum
Time frame: index procedure (day 0)
postoperative ventilator support time
Time frame: index procedure (day 0)
postoperative hospital stay
Time frame: 7 days after operation or before discharge
costs
Time frame: 7 days after operation or before discharge
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