Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect

Chinese Academy of Medical Sciences, Fuwai Hospital

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Perimembranous Ventricular Septal Defect

Treatments: Procedure: transthoracic device closure; Procedure: surgical repair

Study type: Interventional

Funder types: Other

Identifiers

NCT02644330

2015-ZH39

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 3+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

surgical group

Active Comparator group

Description:

The patients in Group A (surgical group) underwent surgical repair with cardiopulmonary bypass

Treatment:

Procedure: surgical repair

closure group

Experimental group

Description:

The patients in Group B (closure group) underwent minimally invasive transthoracic device closure.

Treatment:

Procedure: transthoracic device closure