Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass (CPB)

NCT ID: NCT00921596

Last Updated: 2009-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Heart Defects Heart Valve Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Totally endoscopic cardiac operation

Patients with cardiac diseases undergo cardiac operations with totally endoscopic and cardiopulmonary bypass

Group Type OTHER

cardiac operation with totally endoscopic method

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

thoracoscopic cardiac surgery

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xijing Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dinghua Yi, MD

Role: STUDY_CHAIR

Xijing Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Xijing Hospital

Xi'an, Shannxi, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhenxiao Jin, MD

Role: CONTACT

86-29-84771022

Xuezeng Xu, MD

Role: CONTACT

86-29-84775312

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dinghua Yi, MD

Role: primary

86-29-84775307

Zhenxiao Jin, MD

Role: backup

86-29-84771022

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

xinzangwaike0003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.