Back to resultsHybrid Closure of Congenital Heart Disease
Primary Purpose
Pediatric Ventricular Septal Defects
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sufentanil anesthesia
Hybrid closure
Control
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Ventricular Septal Defects
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Off-pump hybrid closure
Control
Arm Description
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.
Control group: Conventional closure of ventricular septal defects was aided with cardiopulmonary bypass.
Outcomes
Primary Outcome Measures
Myocardial injury as measured by cardiac troponin I serum
Respiratory dysfunction as measured by PaO2
Secondary Outcome Measures
All cause mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02794584
Brief Title
Hybrid Closure of Congenital Heart Disease
Official Title
Precision Assessment of Perioperative Effectiveness and Safety of Transthoracic Minimally Invasive Hybrid Closure for Pediatric Ventricular Septal Defects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Ventricular Septal Defects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Off-pump hybrid closure
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control group: Conventional closure of ventricular septal defects was aided with cardiopulmonary bypass.
Intervention Type
Drug
Intervention Name(s)
sufentanil anesthesia
Other Intervention Name(s)
Sufentanil, Sufenta, (R-30730)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hybrid closure
Other Intervention Name(s)
TTMI: Transthoracic Minimally Invasive
Intervention Description
Hybrid closure of ventricular septal defects through the delivery system without cardiopulmonary bypass by transthoracic minimally invasive small incision.
Intervention Type
Procedure
Intervention Name(s)
Control
Other Intervention Name(s)
CPB: cardiopulmonary bypass
Intervention Description
Surgical closure of ventricular septal defects with cardiopulmonary bypass by routine open thoracotomy.
Primary Outcome Measure Information:
Title
Myocardial injury as measured by cardiac troponin I serum
Time Frame
7 days postoperatively after cardiac surgery
Title
Respiratory dysfunction as measured by PaO2
Time Frame
7 days postoperatively after cardiac surgery
Secondary Outcome Measure Information:
Title
All cause mortality
Time Frame
7 days postoperatively after cardiac surgery
Other Pre-specified Outcome Measures:
Title
Number of participants with right bundle branch block assessed by ECG
Time Frame
7 days postoperatively after cardiac surgery
Title
Left ventricular ejection fractions
Time Frame
7 days postoperatively after cardiac surgery
Title
Extravascular lung water index
Time Frame
7 days postoperatively after cardiac surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hai-tao Gu, MD, PhD
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
14752435
Citation
Amin Z, Danford DA, Lof J, Duncan KF, Froemming S. Intraoperative device closure of perimembranous ventricular septal defects without cardiopulmonary bypass: preliminary results with the perventricular technique. J Thorac Cardiovasc Surg. 2004 Jan;127(1):234-41. doi: 10.1016/j.jtcvs.2003.08.023.
Results Reference
background
PubMed Identifier
29941505
Citation
Liu H, Lu FX, Zhou J, Yan F, Qian SC, Li XY, Zheng SQ, Chen JQ, Zhong JS, Feng QL, Ding T, Fan J, Gu HT, Liu XC. Minimally invasive perventricular versus open surgical ventricular septal defect closure in infants and children: a randomised clinical trial. Heart. 2018 Dec;104(24):2035-2043. doi: 10.1136/heartjnl-2017-312793. Epub 2018 Jun 25.
Results Reference
derived
Learn more about this trial
Hybrid Closure of Congenital Heart Disease
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