Hybrid Closure of Congenital Heart Disease

June 25, 2017 updated by: Hong Liu, Nanjing Medical University

Precision Assessment of Perioperative Effectiveness and Safety of Transthoracic Minimally Invasive Hybrid Closure for Pediatric Ventricular Septal Defects

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • confirmed diagnosis of perimembranous ventricular septal defect, muscular ventricular septal defect, doubly committed subarterial VSD by transesophageal echocardiogram (TEE) with VSD size 5-12mm;
  • no significant aortic insufficiency or aortic valve prolapse.

Exclusion Criteria:

  • confirmed pulmonary hypertension (systolic pulmonary arterial pressure >75mmHg or pulmonary vascular resistance >8.0 Wood U/m2);
  • more than mild degree of aortic regurgitation and obvious aortic valve prolapse;
  • preoperative congestive heart failure;
  • other coexisting cardiac anomalies;
  • infective endocarditis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Off-pump hybrid closure
Hybrid closure is that a periventricular technique uses an occluding device to closure ventricular septal defects of patients through the delivery system by transthoracic minimally invasive small incision without cardiopulmonary bypass.
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.
Other Names:
  • Sufentanil, Sufenta, (R-30730)
Procedure: Hybrid closure
Hybrid closure of ventricular septal defects through the delivery system without cardiopulmonary bypass by transthoracic minimally invasive small incision.
Other Names:
  • TTMI: Transthoracic Minimally Invasive
Placebo Comparator: Control
Control group: Conventional closure of ventricular septal defects was aided with cardiopulmonary bypass.
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.
Other Names:
  • Sufentanil, Sufenta, (R-30730)
Procedure: Control
Surgical closure of ventricular septal defects with cardiopulmonary bypass by routine open thoracotomy.
Other Names:
  • CPB: cardiopulmonary bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Myocardial injury as measured by cardiac troponin I serum
Time Frame: 7 days postoperatively after cardiac surgery
7 days postoperatively after cardiac surgery
Respiratory dysfunction as measured by PaO2
Time Frame: 7 days postoperatively after cardiac surgery
7 days postoperatively after cardiac surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: 7 days postoperatively after cardiac surgery
7 days postoperatively after cardiac surgery

Other Outcome Measures

Outcome Measure
Time Frame
Number of participants with right bundle branch block assessed by ECG
Time Frame: 7 days postoperatively after cardiac surgery
7 days postoperatively after cardiac surgery
Left ventricular ejection fractions
Time Frame: 7 days postoperatively after cardiac surgery
7 days postoperatively after cardiac surgery
Extravascular lung water index
Time Frame: 7 days postoperatively after cardiac surgery
7 days postoperatively after cardiac surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

June 4, 2016

First Posted (Estimate)

June 9, 2016

Study Record Updates

Last Update Posted (Actual)

June 27, 2017

Last Update Submitted That Met QC Criteria

June 25, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD-Nanjing

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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