A Randomized Controlled Trial:Treatments on Infundibular Ventricular Septal Defect

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

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.

Study Overview

• Status: Completed
• 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
• Intervention / Treatment: Device: TEE-guided perventricular device closure without CBP; Procedure: Surgery repair with CBP

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 Type: Interventional
• Enrollment (Actual): 20121212
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Surgery Building of 1st Affiliated Hospital of Nanchang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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; Other Names: TPDC; Procedure: Surgery repair with CBP; Traditional surgery repair under the CBP.; Other Names: SR
Experimental: SR group; Patients who matched inclusion criteria and randomly assigned into SR group underwent the surgery repair with CBP.	Procedure: Surgery repair with CBP; Traditional surgery repair under the CBP.; Other Names: SR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization costs	The hospitalization costs calculated from hospital admission to hospital discharge	1 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay (post-op)	Length of hospital stay refers in particular to the post-op stay in hospital.	1 months
Mean bleeding volume	The mean bleeding volume only referred during the procedure	6 hours
Volume of drainage	The volume of drainage is calculated from being moved off operating table to being pulled out drainage tube.	1 weeks
Procedure time	The procedure time is from skin cut to skin suture	6 hours

Collaborators and Investigators

• Sponsor: Bentong Yu
• Collaborators: The Third Affiliated Hospital of Nanchang University
• Investigators: Study Director: Bentong Yu, MD, 1st Affiliaed Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 29, 2015
• First Submitted That Met QC Criteria: February 6, 2015
• First Posted (Estimate): February 11, 2015

Study Record Updates

• Last Update Posted (Estimate): February 11, 2015
• Last Update Submitted That Met QC Criteria: February 6, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: occlusion; Infundibular Ventricular Septal Defect; TEE-guided; asymmetric occluder; surgical repair
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Transposition of Great Vessels; Heart Septal Defects; Heart Septal Defects, Ventricular; Double Outlet Right Ventricle
• Other Study ID Numbers: HCQ-2012-80-SXHZJH-1