A Randomized Controlled Trial:Treatments on Infundibular Ventricular Septal Defect

Heart Septal Defects, Ventricular Clinical Trial

Official title:

TEE-guided Perventricular Device Closure Through Minithoracotomy vs Traditional Surgery Repair Via CBP in Treatment of Infundibular Ventricular Septal Defect：A Two-center Clinical Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361008
• Other study ID #: HCQ-2012-80-SXHZJH-1
• Status: Completed
• Phase: N/A
• First received: January 29, 2015
• Last updated: February 6, 2015
• Start date: December 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: The First Affiliated Hospital of Nanchang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: The Science and Technology Bureau of Nanchang City
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the security and validity of transesophageal echocardiography(TEE)-guided perventricular device closure(TPDC) through minithoracotomy in treatment of infundibular ventricular septal defect(IVSD) with asymmetric occluder.

Description:

Ventricular septal defect(VSD) , which accounted for about 20% of all congenital heart defects (CHDs) , is among the most common congenital heart malformations，among which infundibular ventricular septal defects(IVSD) is the least common type(18%）.Multiple names for IVSD are in use. They can also be labeled conal VSD, subpulmonary VSD, subarterial VSD, doubly committed VSD, intracristal VSD，or supracristal VSD. These multiple denominations are not attached to specifically different anatomic subtypes.At present, the main methods to treat the specific anatomic condition contain conventional surgical repair(SR) and transcatheter interventional closure. The former need extracorporeal circulation，thus the side effects of extracorporeal circulation are inevitable，such as on the central nervous system, respiratory system, urinary system, etc. Although the latter has the characteristics of minimally invasive, patients should be exposed in X-ray withstanding potential risk of radiation. On the other hand，there are limits with age for patients who underwent transcatheter closure because of small vessel size. Fully developed blood vessels are to reach a certain diameter, but children need be up to 3 years old or so. In addition,the aortic valve was easily injured by wire and atrioventricular block was reported.Since the surrounding structure is complicated and the defect is too high, device closure of an IVSD is difficult to succeed in transcatheter approach. Traditional repair via cardiopulmonary bypass(CBP) is widely used to treat this kind of diseases. Past decade，with the development of technology and society，TEE-guided surgical occlusion through minithoracotomy was used to treat CHDs in an increasing number of popularity，avoiding the inherent risks of cardiopulmonary bypass and radiation,etc. But it is rarely reported to treat IVSD by minimally invasive perventricular device closure without CBP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20121212
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 70 Years

Eligibility

Inclusion Criteria:

(1) patients with single IVSD indicated by TTE,without concomitant cardiac malformation, serious arrhythmia or other important non-cardiac diseases;(2) patients whose ventricular septal defects from aortic residual < 3 mm, preoperative without aortic regurgitation or only mild reflux, defect size =10 mm;

Exclusion Criteria:

(1) defect size > 10 mm in diameter; (2) Preoperative with above moderate aortic valve prolapse (or) closed incompletely; (3) Eisenmenger syndrome caused by pulmonary hypertension,(4)decide temporarily to change method before surgery;(5) not signed informed consent application

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Double Outlet Right Ventricle
• Double Outlet Right Ventricle, Noncommitted VSD
• Double Outlet Right Ventricle, Subaortic VSD
• Double Outlet Right Ventricle, Subpulmonary VSD
• Heart Septal Defects
• Heart Septal Defects, Ventricular
• Supracristal Ventricular Septal Defect

Intervention

Device:
• TEE-guided perventricular device closure without CBP
Perventricular device closure through minithoracotomy under the TEE-guidance without CBP.The device is an eccentric occluder made by Shanghai Shape Memory Alloy Co.,Ltd in Shanghai,China

Procedure:
• Surgery repair with CBP
Traditional surgery repair under the CBP.

Locations

Country	Name	City	State
China	Surgery Building of 1st Affiliated Hospital of Nanchang University	Nanchang	Jiangxi

Sponsors (2)

Lead Sponsor	Collaborator
Bentong Yu	The Third Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay (post-op)	Length of hospital stay refers in particular to the post-op stay in hospital.	1 months	No
Other	Mean bleeding volume	The mean bleeding volume only referred during the procedure	6 hours	No
Other	Volume of drainage	The volume of drainage is calculated from being moved off operating table to being pulled out drainage tube.	1 weeks	No
Other	Procedure time	The procedure time is from skin cut to skin suture	6 hours	No
Primary	Surgery success rate	Surgery success means that patients in both TPDC and SR group don't change their surgery type either undergo a repeat surgery.	two months	No
Secondary	Hospitalization costs	The hospitalization costs calculated from hospital admission to hospital discharge	1 months	No