Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect

Perimembranous Ventricular Septal Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02644330
• Other study ID #: 2015-ZH39
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 28, 2015
• Last updated: December 30, 2015
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: December 2015
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Xiangbin Pan, Dr
• Phone: 010-88396666
• Email: fuwaiyiyuan28[@]163.cpm
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Septal Defects
• Heart Septal Defects, Ventricular
• Perimembranous Ventricular Septal Defect

Intervention

Procedure:
• transthoracic device closure
minimally invasive transthoracic device closure
• surgical repair
surgical repair with cardiopulmonary bypass

Locations

Country	Name	City	State
China	XiangYa Hospital CentralSouth University	Changsha	Hunan
China	The First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Henan Province People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the success rate of the operation	The definition of a successful operation: shunt disappeared	index procedure (day 0)	Yes
Secondary	adverse events	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	12 months	Yes
Secondary	thoracic fluid volume		index procedure (day 0)	No
Secondary	blood transfusion		index procedure (day 0)	No
Secondary	operating time	time cost from cut the skin to complete closure of the sternum	index procedure (day 0)	No
Secondary	postoperative ventilator support time		index procedure (day 0)	No
Secondary	postoperative hospital stay		7 days after operation or before discharge	No
Secondary	costs		7 days after operation or before discharge	No