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Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass (CPB)

A

Air Force Military Medical University of People's Liberation Army

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Heart Valve Diseases
Congenital Heart Defects

Treatments

Procedure: cardiac operation with totally endoscopic method

Study type

Interventional

Funder types

Other

Identifiers

NCT00921596
xinzangwaike0003

Details and patient eligibility

About

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.

Enrollment

800 estimated patients

Sex

All

Ages

2 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

800 participants in 1 patient group

Totally endoscopic cardiac operation
Other group
Description:
Patients with cardiac diseases undergo cardiac operations with totally endoscopic and cardiopulmonary bypass
Treatment:
Procedure: cardiac operation with totally endoscopic method

Trial contacts and locations

1

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Central trial contact

Xuezeng Xu, MD; Zhenxiao Jin, MD

Data sourced from clinicaltrials.gov

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