Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect

Phase 2

• Conditions: Perimembranous Ventricular Septal Defect
• Interventions: Procedure: transthoracic device closure; Procedure: surgical repair

• Registration Number: NCT02644330
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Timeline

• Study Start: 2015-10
• Status Verified: 2015-12
• Study First Submitted: 2015-12-28
• Study First Submitted QC: 2015-12-30
• Last Update Submitted: 2015-12-30
• Study First Posted: 2015-12-31
• Last Update Posted: 2015-12-31
• Primary Completion: 2016-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
closure group	transthoracic device closure	The patients in Group B (closure group) underwent minimally invasive transthoracic device closure.
surgical group	surgical repair	The patients in Group A (surgical group) underwent surgical repair with cardiopulmonary bypass

Primary Outcome Measures

Name	Time	Method
the success rate of the operation	index procedure (day 0)	The definition of a successful operation: shunt disappeared

Secondary Outcome Measures

Name	Time	Method
thoracic fluid volume	index procedure (day 0)
postoperative hospital stay	7 days after operation or before discharge
operating time	index procedure (day 0)	time cost from cut the skin to complete closure of the sternum
postoperative ventilator support time	index procedure (day 0)
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
costs	7 days after operation or before discharge
blood transfusion	index procedure (day 0)

Trial Locations

Locations (3)

XiangYa Hospital CentralSouth University; 🇨🇳 Changsha, Hunan, China

Henan Province People's Hospital; 🇨🇳 Zhengzhou, Henan, China

The First Affiliated Hospital of Kunming Medical University; 🇨🇳 Kunming, Yunnan, China