Clinical trial NCT02644330: Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect
Official title: A Randomized Controlled Trial of Minimally Invasive Transthoracic Device Closure in the Treatment of Patients With Perimembranous Ventricular Septal Defect
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Perimembranous Ventricular Septal Defect
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: the success rate of the operation
timeFrame: index procedure (day 0)
Secondary outcomes:
measure: adverse events
timeFrame: 12 months
measure: thoracic fluid volume
timeFrame: index procedure (day 0)
measure: blood transfusion
timeFrame: index procedure (day 0)
measure: operating time
timeFrame: index procedure (day 0)
measure: postoperative ventilator support time
timeFrame: index procedure (day 0)
measure: postoperative hospital stay
timeFrame: 7 days after operation or before discharge
measure: costs
timeFrame: 7 days after operation or before discharge
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Province People's Hospital
state: Henan
city: Changsha
country: China
facility: XiangYa Hospital CentralSouth University
state: Hunan
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xiangbin Pan, Dr
role: PRINCIPAL_INVESTIGATOR
References: