Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass (CPB)

Phase 1

• Conditions: Congenital Heart Defects; Heart Valve Diseases
• Interventions: Procedure: cardiac operation with totally endoscopic method

• Registration Number: NCT00921596
• Lead Sponsor: Xijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01
• Status Verified: 2009-06
• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-14
• Last Update Submitted: 2009-06-14
• Study First Posted: 2009-06-16
• Last Update Posted: 2009-06-16
• Primary Completion: 2009-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Totally endoscopic cardiac operation	cardiac operation with totally endoscopic method	Patients with cardiac diseases undergo cardiac operations with totally endoscopic and cardiopulmonary bypass

Primary Outcome Measures

Name	Time	Method
all cause mortality	one year

Secondary Outcome Measures

Name	Time	Method
all cause morbidity	one year

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shannxi, China