Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Perimembranous Ventricular Septal Defect

Intervention / Treatment
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* Procedure: transthoracic device closure
* Procedure: surgical repair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: surgical group<br>The patients in Group A (surgical group) underwent surgical repair with cardiopulmonary bypass | Procedure: surgical repair<br>* surgical repair with cardiopulmonary bypass<br>|
| Experimental: closure group<br>The patients in Group B (closure group) underwent minimally invasive transthoracic device closure. | Procedure: transthoracic device closure<br>* minimally invasive transthoracic device closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the success rate of the operation | The definition of a successful operation: shunt disappeared | index procedure (day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 
| thoracic fluid volume |  | index procedure (day 0) | 
| blood transfusion |  | index procedure (day 0) | 
| operating time | time cost from cut the skin to complete closure of the sternum | index procedure (day 0) | 
| postoperative ventilator support time |  | index procedure (day 0) | 
| postoperative hospital stay |  | 7 days after operation or before discharge | 
| costs |  | 7 days after operation or before discharge |