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临床试验/NCT02361008
NCT02361008已完成不适用

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

Bentong Yu1 个研究点 分布在 1 个国家目标入组 20,121,212 人开始时间: 2012年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20,121,212
试验地点
1
主要终点
Surgery success rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

入排标准

年龄范围
7 Days 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •(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;

排除标准

  • •(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

研究组 & 干预措施

TPDC group

Experimental

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.

干预措施: TEE-guided perventricular device closure without CBP (Device)

TPDC group

Experimental

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.

干预措施: Surgery repair with CBP (Procedure)

SR group

Experimental

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

干预措施: Surgery repair with CBP (Procedure)

结局指标

主要结局

Surgery success rate

时间窗: two months

Surgery success means that patients in both TPDC and SR group don't change their surgery type either undergo a repeat surgery.

次要结局

  • Hospitalization costs(1 months)

研究者

发起方
Bentong Yu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bentong Yu

Director of Thoracic and Cardiovascular Surgery Department

The First Affiliated Hospital of Nanchang University

研究点 (1)

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