Hybrid Closure of Congenital Heart Disease

NCT02794584 | Completed DMC

• 1 other identifier: CHD-Nanjing
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Myocardial injury as measured by cardiac troponin I serum

  7 days postoperatively after cardiac surgery

• Respiratory dysfunction as measured by PaO2

  7 days postoperatively after cardiac surgery

Secondary Outcomes (1)

• All cause mortality

  7 days postoperatively after cardiac surgery

Other Outcomes (3)

• Number of participants with right bundle branch block assessed by ECG

  7 days postoperatively after cardiac surgery

• Left ventricular ejection fractions

  7 days postoperatively after cardiac surgery

• Extravascular lung water index

  7 days postoperatively after cardiac surgery

Study Arms (2)

Off-pump hybrid closure

ACTIVE COMPARATOR

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; Procedure: Hybrid closure

Control

PLACEBO COMPARATOR

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

Drug: sufentanil anesthesia; Procedure: Control

Interventions

sufentanil anesthesia 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.

Also known as: Sufentanil, Sufenta, (R-30730)

Control; Off-pump hybrid closure

Hybrid closure PROCEDURE

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

Also known as: TTMI: Transthoracic Minimally Invasive

Off-pump hybrid closure

Control PROCEDURE

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

Also known as: CPB: cardiopulmonary bypass

Control

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Medical University: lead

Related Publications (2)

• 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.

  PMID: 14752435 BACKGROUND

• 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.

  PMID: 29941505 DERIVED

MeSH Terms

Interventions

Sufentanil; Coronary Artery Bypass

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Hai-tao Gu, MD, PhD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 9, 2016
• Study Start: January 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 27, 2017

Record last verified: 2017-06