Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass (CPB) (CPB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00921596
Recruitment Status : Unknown
Verified June 2009 by Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : June 16, 2009
Last Update Posted : June 16, 2009
Information provided by:
Xijing Hospital

Brief Summary:
Conventional cardiac operations are performed with median sternotomy, which is related to great wound, morbidities, longer duration in hospital and most significantly, cosmetic problems. The investigators invested a new minimally invasive cardiac operation method totally under video-endoscope and peripheral cardiopulmonary bypass. The investigators' hypothesis is that this new minimally method could provide better cosmetic effects to the patients, and also relate to shorter postoperative hospital stay and better recovery.

Condition or disease Intervention/treatment Phase
Congenital Heart Defects Heart Valve Diseases Procedure: cardiac operation with totally endoscopic method Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass, a Single Center's Experience
Study Start Date : January 2000
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Totally endoscopic cardiac operation
Patients with cardiac diseases undergo cardiac operations with totally endoscopic and cardiopulmonary bypass
Procedure: cardiac operation with totally endoscopic method
Cardiac operations are performed with three keyholes in the right chest wall. Video images are obtained by digital thoracoscope through one hole. Intracardiac lesions are accessed with surgical instruments and repaired through the other two holes. Cardiopulmonary bypass is set up with femoral cannulations. Moderate system hypothermic is applied for the operation. Cardiac arrest is achieved with ascending aorta clamp and cardioplegia solution delivery through aortic root cannulation. After the intracardiac lesions are repaired, aortic clamp is removed, and the heart is reperfused to restore its spontaneous rhythm. After the patients are rewarmed to normal temperature, CPB is discontinued. Femoral cannulations are removed, and surgical wounds are closed.
Other Name: thoracoscopic cardiac surgery

Primary Outcome Measures :
  1. all cause mortality [ Time Frame: one year ]

Secondary Outcome Measures :
  1. all cause morbidity [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • congenital heart defects or heart valve diseases require surgical correction

Exclusion Criteria:

  • Body weight < 10kg
  • committed with complex congenital heart defect
  • anticipated to perform aortic valve repair or replacement
  • anticipated to perform aorta repair or replacement
  • committed with Femoral vessel diseases unable to perform femoral cannulation
  • refuse to perform totally thoracoscope minimally invasive surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00921596

Contact: Zhenxiao Jin, MD 86-29-84771022
Contact: Xuezeng Xu, MD 86-29-84775312

China, Shannxi
Xijing Hospital Recruiting
Xi'an, Shannxi, China, 710032
Contact: Dinghua Yi, MD    86-29-84775307   
Contact: Zhenxiao Jin, MD    86-29-84771022   
Principal Investigator: Zhenxiao Jin, MD         
Principal Investigator: Shiqiang Yu, MD         
Principal Investigator: Xuezeng Xu, MD         
Sponsors and Collaborators
Xijing Hospital
Study Chair: Dinghua Yi, MD Xijing Hospital

Responsible Party: Shiqiang Yu, Xijing Hospital Identifier: NCT00921596     History of Changes
Other Study ID Numbers: xinzangwaike0003
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: June 16, 2009
Last Verified: June 2009

Keywords provided by Xijing Hospital:
Surgical Procedures, Cardiac
Minimally Invasive Surgical Procedures
Cardiopulmonary Bypass

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Valve Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities