A Randomized Controlled Trial:Treatments on Infundibular Ventricular Septal Defect

Not Applicable

Completed

• Conditions: Supracristal Ventricular Septal Defect; Double Outlet Right Ventricle, Subpulmonary VSD; Heart Septal Defects, Ventricular; Double Outlet Right Ventricle, Subaortic VSD; Double Outlet Right Ventricle, Noncommitted VSD
• Interventions: Procedure: Surgery repair with CBP; Device: TEE-guided perventricular device closure without CBP

• Registration Number: NCT02361008
• Lead Sponsor: Bentong Yu

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.

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2015-01-29
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-06
• Last Update Submitted: 2015-02-06
• Study First Posted: 2015-02-11
• Last Update Posted: 2015-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20121212

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SR group	Surgery repair with CBP	Patients who matched inclusion criteria and randomly assigned into SR group underwent the surgery repair with CBP.
TPDC group	TEE-guided perventricular device closure without CBP	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.
TPDC group	Surgery repair with CBP	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.

Primary Outcome Measures

Name	Time	Method
Surgery success rate	two months	Surgery success means that patients in both TPDC and SR group don't change their surgery type either undergo a repeat surgery.

Secondary Outcome Measures

Name	Time	Method
Hospitalization costs	1 months	The hospitalization costs calculated from hospital admission to hospital discharge

Trial Locations

Locations (1)

Surgery Building of 1st Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China