MedTrace Logo

A Randomized Controlled Trial:Treatments on Infundibular Ventricular Septal Defect

NCT02361008 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20121212

Last updated 2015-02-11

No results posted yet for this study

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.

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

Interventions

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

PROCEDURE

Surgery repair with CBP

Traditional surgery repair under the CBP.

Sponsors & Collaborators

  • The Third Affiliated Hospital of Nanchang University

    collaborator OTHER

  • Bentong Yu

    lead OTHER

Principal Investigators

  • Bentong Yu, MD · 1st Affiliaed Hospital of Nanchang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Days
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02361008 on ClinicalTrials.gov