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Hybrid Closure of Congenital Heart Disease

NCT02794584 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-06-27

No results posted yet for this study

Summary

Ventricular septal defect (VSD) is one of the most common pediatric congenital malformations. In recent years, in view of the rapid rise of transthoracic minimally invasive hybrid closure for pediatric VSD in the clinical practice, precision assessment of perioperative its effectiveness and safety has already become an important issue that must be solved. On the basis of echocardiography, integrating with characteristics associated critical care, the investigators focus on precision assessment of perioperative effectiveness and safety of transthoracic hybrid closure for pediatric VSD, compared with conventional surgical sternotomy repair with cardiopulmonary bypass (CPB).

Conditions

  • Pediatric Ventricular Septal Defects

Interventions

DRUG

sufentanil anesthesia

Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. During extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations.

PROCEDURE

Hybrid closure

Hybrid closure of ventricular septal defects through the delivery system without cardiopulmonary bypass by transthoracic minimally invasive small incision.

PROCEDURE

Control

Surgical closure of ventricular septal defects with cardiopulmonary bypass by routine open thoracotomy.

Sponsors & Collaborators

  • Nanjing Medical University

    lead OTHER

Principal Investigators

  • Hai-tao Gu, MD, PhD · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2016-12-31
Completion
2016-12-31

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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 NCT02794584 on ClinicalTrials.gov