Hybrid Closure of Congenital Heart Disease

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Brief Title

Hybrid Closure of Congenital Heart Disease

Official Title

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

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).
    



Study Type

Interventional


Primary Outcome

Myocardial injury as measured by cardiac troponin I serum

Secondary Outcome

 All cause mortality

Condition

Pediatric Ventricular Septal Defects

Intervention

sufentanil anesthesia

Study Arms / Comparison Groups

 Off-pump hybrid closure
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

200

Start Date

January 2011

Completion Date

December 2016

Primary Completion Date

December 2016

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.
      

Gender

All

Ages

1 Year - 5 Years

Accepts Healthy Volunteers

No

Contacts

Hai-tao Gu, MD, PhD, , 



Administrative Informations


NCT ID

NCT02794584

Organization ID

CHD-Nanjing


Responsible Party

Principal Investigator

Study Sponsor

Nanjing Medical University


Study Sponsor

Hai-tao Gu, MD, PhD, Principal Investigator, The First Affiliated Hospital with Nanjing Medical University


Verification Date

June 2017