Completed

NCT Number: NCT02794584

Hybrid Closure of Congenital Heart Disease

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pediatric Ventricular Septal Defects

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Sufentanil, Sufenta, (R-30730)

Hybrid closure

Procedure

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

Other names: TTMI: Transthoracic Minimally Invasive

Control

Procedure

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

Other names: CPB: cardiopulmonary bypass

Primary outcomes

Myocardial injury as measured by cardiac troponin I serum

Time frame: 7 days postoperatively after cardiac surgery
Respiratory dysfunction as measured by PaO2

Time frame: 7 days postoperatively after cardiac surgery

Secondary outcomes

All cause mortality

Time frame: 7 days postoperatively after cardiac surgery

Other outcomes

Number of participants with right bundle branch block assessed by ECG

Time frame: 7 days postoperatively after cardiac surgery
Left ventricular ejection fractions

Time frame: 7 days postoperatively after cardiac surgery
Extravascular lung water index

Time frame: 7 days postoperatively after cardiac surgery

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Jun 9, 2016
Registry last updated: Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.