A Randomized Controlled Trial:Treatments on Infundibular Ventricular Septal Defect

NCT ID: NCT02361008

Last Updated: 2015-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20121212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-12-31

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TPDC group

Patients who matched inclusion criteria and randomly divided into TPDC group underwent the TEE-guided perventricular device closure without CBP. But of them,who underwent TPDC failure during the procedure would be dropped out of the trial.

Group Type: EXPERIMENTAL

TEE-guided perventricular device closure without CBP

Intervention Type: DEVICE

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

Surgery repair with CBP

Intervention Type: PROCEDURE

Traditional surgery repair under the CBP.

SR group

Patients who matched inclusion criteria and randomly assigned into SR group underwent the surgery repair with CBP.

Group Type: EXPERIMENTAL

Surgery repair with CBP

Intervention Type: PROCEDURE

Traditional surgery repair under the CBP.

Interventions

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

Intervention Type: DEVICE

Surgery repair with CBP

Traditional surgery repair under the CBP.

Intervention Type: PROCEDURE

Other Intervention Names

TPDC; SR

Eligibility Criteria

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

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: collaborator

Bentong Yu

OTHER

Sponsor Role: lead

Responsible Party

Bentong Yu

Director of Thoracic and Cardiovascular Surgery Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bentong Yu, MD

Role: STUDY_DIRECTOR

1st Affiliaed Hospital of Nanchang University

Locations

Surgery Building of 1st Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Countries

China

Other Identifiers

HCQ-2012-80-SXHZJH-1

Identifier Type: -

Identifier Source: org_study_id