Perimembranous Ventricular Septal Defect
Conditions
Brief summary
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
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.
Interventions
PROCEDUREtransthoracic device closure
minimally invasive transthoracic device closure
PROCEDUREsurgical repair
surgical repair with cardiopulmonary bypass
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the success rate of the operation | index procedure (day 0) | The definition of a successful operation: shunt disappeared |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| thoracic fluid volume | index procedure (day 0) | — |
| blood transfusion | index procedure (day 0) | — |
| operating time | index procedure (day 0) | time cost from cut the skin to complete closure of the sternum |
| adverse events | 12 months | 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 |
| postoperative hospital stay | 7 days after operation or before discharge | — |
| costs | 7 days after operation or before discharge | — |
| postoperative ventilator support time | index procedure (day 0) | — |
Countries
China
Contacts
Primary ContactXiangbin Pan, Dr
Outcome results
None listed