NCT00921596UnknownPhase 1
Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass, a Single Center's Experience
Xijing Hospital1 site in 1 country800 target enrollmentStarted: January 1, 2000Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- all cause mortality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
all cause mortality
Time Frame: one year
Secondary Outcomes
- all cause morbidity(one year)
Investigators
Study Sites (1)
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