Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass (CPB)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Xijing Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT00921596
First received: June 12, 2009
Last updated: June 14, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Congenital Heart Defects
Heart Valve Diseases
Procedure: cardiac operation with totally endoscopic method
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass, a Single Center's Experience

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • all cause morbidity [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 800
Study Start Date: January 2000
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Totally endoscopic cardiac operation
Patients with cardiac diseases undergo cardiac operations with totally endoscopic and cardiopulmonary bypass
Procedure: cardiac operation with totally endoscopic method
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.
Other Name: thoracoscopic cardiac surgery

  Eligibility

Ages Eligible for Study:   2 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921596

Contacts
Contact: Zhenxiao Jin, MD 86-29-84771022 jinzx10262@yahoo.com.cn
Contact: Xuezeng Xu, MD 86-29-84775312 xuxuez@fmmu.edu.cn

Locations
China, Shannxi
Xijing Hospital Recruiting
Xi'an, Shannxi, China, 710032
Contact: Dinghua Yi, MD    86-29-84775307    yidinghua@yahoo.com.cn   
Contact: Zhenxiao Jin, MD    86-29-84771022    jinzx10262@yahoo.com.cn   
Principal Investigator: Zhenxiao Jin, MD         
Principal Investigator: Shiqiang Yu, MD         
Principal Investigator: Xuezeng Xu, MD         
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Chair: Dinghua Yi, MD Xijing Hospital
  More Information

No publications provided

Responsible Party: Shiqiang Yu, Xijing Hospital
ClinicalTrials.gov Identifier: NCT00921596     History of Changes
Other Study ID Numbers: xinzangwaike0003
Study First Received: June 12, 2009
Last Updated: June 14, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
Surgical Procedures, Cardiac
Minimally Invasive Surgical Procedures
Thoracoscopes
Cardiopulmonary Bypass

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Valve Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 18, 2014