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Hybrid Closure of Congenital Heart Disease

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ClinicalTrials.gov Identifier: NCT02794584
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Hong Liu, The First Affiliated Hospital with Nanjing Medical University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Pediatric Ventricular Septal Defects Drug: sufentanil anesthesia Procedure: Hybrid closure Procedure: Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Precision Assessment of Perioperative Effectiveness and Safety of Transthoracic Minimally Invasive Hybrid Closure for Pediatric Ventricular Septal Defects
Actual Study Start Date : January 2011
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

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Arms and Interventions
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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 Name: 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 Name: 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 Name: Sufentanil, Sufenta, (R-30730)

Procedure: Control
Surgical closure of ventricular septal defects with cardiopulmonary bypass by routine open thoracotomy.
Other Name: CPB: cardiopulmonary bypass


Outcome Measures
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Primary Outcome Measures :
  1. Myocardial injury as measured by cardiac troponin I serum [ Time Frame: 7 days postoperatively after cardiac surgery ]
  2. Respiratory dysfunction as measured by PaO2 [ Time Frame: 7 days postoperatively after cardiac surgery ]

Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 7 days postoperatively after cardiac surgery ]

Other Outcome Measures:
  1. Number of participants with right bundle branch block assessed by ECG [ Time Frame: 7 days postoperatively after cardiac surgery ]
  2. Left ventricular ejection fractions [ Time Frame: 7 days postoperatively after cardiac surgery ]
  3. Extravascular lung water index [ Time Frame: 7 days postoperatively after cardiac surgery ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794584


Sponsors and Collaborators
Nanjing Medical University
Investigators
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Principal Investigator: Hai-tao Gu, MD, PhD The First Affiliated Hospital with Nanjing Medical University
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hong Liu, Principal Investigator, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02794584    
Other Study ID Numbers: CHD-Nanjing
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Heart Septal Defects
Heart Septal Defects, Ventricular
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sufentanil
Dsuvia
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General