Hybrid Closure of Congenital Heart Disease

Pediatric Ventricular Septal Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794584
• Other study ID #: CHD-Nanjing
• Status: Completed
• Phase: N/A
• First received: May 25, 2016
• Last updated: June 25, 2017
• Start date: January 2011
• Est. completion date: December 2016

Study information

• Verified date: June 2017
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Septal Defects
• Heart Septal Defects, Ventricular
• Pediatric Ventricular Septal Defects

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with right bundle branch block assessed by ECG		7 days postoperatively after cardiac surgery
Other	Left ventricular ejection fractions		7 days postoperatively after cardiac surgery
Other	Extravascular lung water index		7 days postoperatively after cardiac surgery
Primary	Myocardial injury as measured by cardiac troponin I serum		7 days postoperatively after cardiac surgery
Primary	Respiratory dysfunction as measured by PaO2		7 days postoperatively after cardiac surgery
Secondary	All cause mortality		7 days postoperatively after cardiac surgery