Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass (CPB) (CPB)
Primary Purpose
Congenital Heart Defects, Heart Valve Diseases
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
cardiac operation with totally endoscopic method
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Defects focused on measuring Surgical Procedures, Cardiac, Minimally Invasive Surgical Procedures, Thoracoscopes, Cardiopulmonary Bypass
Eligibility Criteria
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
Sites / Locations
- Xijing HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Totally endoscopic cardiac operation
Arm Description
Patients with cardiac diseases undergo cardiac operations with totally endoscopic and cardiopulmonary bypass
Outcomes
Primary Outcome Measures
all cause mortality
Secondary Outcome Measures
all cause morbidity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00921596
Brief Title
Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass (CPB)
Acronym
CPB
Official Title
Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass, a Single Center's Experience
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2000 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Xijing Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Defects, Heart Valve Diseases
Keywords
Surgical Procedures, Cardiac, Minimally Invasive Surgical Procedures, Thoracoscopes, Cardiopulmonary Bypass
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Totally endoscopic cardiac operation
Arm Type
Other
Arm Description
Patients with cardiac diseases undergo cardiac operations with totally endoscopic and cardiopulmonary bypass
Intervention Type
Procedure
Intervention Name(s)
cardiac operation with totally endoscopic method
Other Intervention Name(s)
thoracoscopic cardiac surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
all cause mortality
Time Frame
one year
Secondary Outcome Measure Information:
Title
all cause morbidity
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenxiao Jin, MD
Phone
86-29-84771022
Email
jinzx10262@yahoo.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xuezeng Xu, MD
Phone
86-29-84775312
Email
xuxuez@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dinghua Yi, MD
Organizational Affiliation
Xijing Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shannxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dinghua Yi, MD
Phone
86-29-84775307
Email
yidinghua@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Zhenxiao Jin, MD
Phone
86-29-84771022
Email
jinzx10262@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Zhenxiao Jin, MD
First Name & Middle Initial & Last Name & Degree
Shiqiang Yu, MD
First Name & Middle Initial & Last Name & Degree
Xuezeng Xu, MD
12. IPD Sharing Statement
Learn more about this trial
Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass (CPB)
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