A Retrospective Study to Collect the Data From the Patients Who Had the Perimount Heart Valve Replacement Surgery in China During 2001 to 2007

Edwards Lifesciences

Status: Completed

Conditions: Mitral Valve or Aortic Valve Replacement

Treatments: Device: Perimount 2900/6900 Heart Valve

Study type: Observational

Funder types: Industry

Identifiers

NCT02381678

Edwards-CN-001

Details and patient eligibility

About

The objective of the study is to obtain the clinical data from patients who had the Perimount Heat Valve (Type:6900P and 2900) Replacement Surgery in Guangdong General Hospital during 2001-2007 in order to evaluate the performace of this heart valve prothesis and collect the patients' post-operation infomation including the current living status, mortality rate, and the possibility of re-operation，bleeding and thrombosis.

This is a retrospective , observentional clinical study to be conducted in Guangdong General Hospital in China. This study will enroll up to 200 patients.

Enrollment: 225 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patients who implanted with Perimount Heart Valve (Type: 6900P and 2900) during 2001-2007 in Guangdong General Hospital in China
• The patients agree to join the study and sign the ICF

Exclusion criteria

• No specific exclusion criteria

Trial design

225 participants in 1 patient group

Subjects implanted with Perimount Heart Valve

Description:

Only one group was set for this study, including all enrolled subjects who implanted with Perimount Heart Valve during 2001 to 2007

Treatment:

Device: Perimount 2900/6900 Heart Valve