Hybrid Closure of Congenital Heart Disease

NCT ID: NCT02794584

Last Updated: 2017-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2016-12-31

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).

Conditions

Pediatric Ventricular Septal Defects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

sufentanil anesthesia

Intervention Type: DRUG

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.

Hybrid closure

Intervention Type: PROCEDURE

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

Control

Control group: Conventional closure of ventricular septal defects was aided with cardiopulmonary bypass.

Group Type: PLACEBO_COMPARATOR

sufentanil anesthesia

Intervention Type: DRUG

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.

Control

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: DRUG

Hybrid closure

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

Intervention Type: PROCEDURE

Control

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

Intervention Type: PROCEDURE

Other Intervention Names

Sufentanil, Sufenta, (R-30730); TTMI: Transthoracic Minimally Invasive; CPB: cardiopulmonary bypass

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hong Liu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hai-tao Gu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

References

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.

Reference Type: BACKGROUND

PMID: 14752435 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29941505 (View on PubMed)

Other Identifiers

CHD-Nanjing

Identifier Type: -

Identifier Source: org_study_id