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Clinical Trials/NCT00921596
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:
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Conditions

Trial Snapshot

Phase
Phase 1
Sponsor
Enrollment
800
Locations
1
Primary Endpoint
all cause mortality
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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

Sponsor
Xijing Hospital
Sponsor Class
Other

Study Sites (1)

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