NCT02381678

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 225 (actual)
• Sponsor: Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Mitral Valve or Aortic Valve Replacement

Interventions

Type	Name	Description
DEVICE	Perimount 2900/6900 Heart Valve	This is a retrospective study which ask the subjects implanted with Perimount Heart Valve during 2001 to 2007 back hospital for follow up visit.

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-11-01
• Completion: 2016-01-01
• First posted: 2015-03-06
• Last updated: 2016-10-17
• Results posted: 2016-10-17

Locations

1 site across 1 country: China