Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass (CPB)
CPB
1 other identifier
interventional
800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2000
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedFirst Submitted
Initial submission to the registry
June 12, 2009
CompletedFirst Posted
Study publicly available on registry
June 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJune 16, 2009
June 1, 2009
9.9 years
June 12, 2009
June 14, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
all cause mortality
one year
Secondary Outcomes (1)
all cause morbidity
one year
Study Arms (1)
Totally endoscopic cardiac operation
OTHERPatients with cardiac diseases undergo cardiac operations with totally endoscopic and cardiopulmonary bypass
Interventions
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.
Eligibility Criteria
You may qualify if:
- congenital heart defects or heart valve diseases require surgical correction
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Xijing Hospital
Xi'an, Shannxi, 710032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dinghua Yi, MD
Xijing Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 12, 2009
First Posted
June 16, 2009
Study Start
January 1, 2000
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
June 16, 2009
Record last verified: 2009-06