Clinical Trial: Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Current Primary Outcome: the success rate of the operation [ Time Frame: index procedure (day 0) ]

The definition of a successful operation: shunt disappeared


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • adverse events [ Time Frame: 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
  • thoracic fluid volume [ Time Frame: index procedure (day 0) ]
  • blood transfusion [ Time Frame: index procedure (day 0) ]
  • operating time [ Time Frame: index procedure (day 0) ]
    time cost from cut the skin to complete closure of the sternum
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Chinese Academy of Medical Sciences, Fuwai Hospital

Dates:
Date Received: December 28, 2015
Date Started: October 2015
Date Completion: October 2017
Last Updated: December 30, 2015
Last Verified: December 2015