A Randomized Controlled Trial:Treatments on Infundibular Ventricular Septal Defect
Condition: 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
MeSH terms: Heart Septal Defects; Heart Septal Defects, Ventricular; Double Outlet Right Ventricle
Study type: Interventional

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.
    

Intervention name(s): TEE-guided perventricular device closure without CBP; Surgery repair with CBP
Intervention type(s): Device; Procedure
Intervention description(s): 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; Traditional surgery repair under the CBP.
Other intervention name(s): TPDC; SR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Infundibular Ventricular Septal Defect; occlusion; TEE-guided; asymmetric occluder; surgical repair