Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass (CPB)

Heart Valve Diseases Clinical Trial

— CPB  

Official title:

Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass, a Single Center's Experience

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00921596
• Other study ID #: xinzangwaike0003
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: June 12, 2009
• Last updated: June 14, 2009
• Start date: January 2000
• Est. completion date: December 2009

Study information

• Verified date: June 2009
• Source: Xijing Hospital
• Contact: Zhenxiao Jin, MD
• Phone: 86-29-84771022
• Email: jinzx10262[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Heart Defects
• Heart Defects, Congenital
• Heart Valve Diseases

Intervention

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.

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shannxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		one year	Yes
Secondary	all cause morbidity		one year	Yes