Perimembranous Ventricular Septal Defect Clinical Trial
Official title:
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04034498 -
A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® PmVSD Occluder in Patients With Perimembranous Ventricular Septal Defects
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