Clinical trial NCT02361008: A Randomized Controlled Trial:Treatments on Infundibular Ventricular Septal Defect
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Keywords: Infundibular Ventricular Septal Defect
occlusion
TEE-guided
asymmetric occluder
surgical repair
Lead sponsor: The First Affiliated Hospital of Nanchang University
Sponsor class: OTHER
Collaborators: name: The Third Affiliated Hospital of Nanchang University
First posted: 2015-02-11
Enrollment: 20121212
Sex: ALL
Minimum age (years): 7
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Surgery success rate
timeFrame: two months
Secondary outcomes:
measure: Hospitalization costs
timeFrame: 1 months
Other outcomes:
measure: Length of hospital stay (post-op)
timeFrame: 1 months
measure: Mean bleeding volume
timeFrame: 6 hours
measure: Volume of drainage
timeFrame: 1 weeks
measure: Procedure time
timeFrame: 6 hours
Locations:
city: Nanchang
country: China
facility: Surgery Building of 1st Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
affiliation: 1st Affiliaed Hospital of Nanchang University
name: Bentong Yu, MD
role: STUDY_DIRECTOR
References: