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

Completed

• Conditions: Mitral Valve or Aortic Valve Replacement

• Registration Number: NCT02381678
• Lead Sponsor: Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-03-05
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-06
• Primary Completion: 2015-11
• Study Completion: 2016-01
• Status Verified: 2016-05
• Results First Submitted: 2016-05-26
• Results First Submitted QC: 2016-08-22
• Last Update Submitted: 2016-08-22
• Results First Posted: 2016-10-17
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography	7-15 years after heart valve replacement surgery (during 2001-2007)	This is a one-arm study. All enrolled 225 subjects are required to be back Gungdong General Hospital to do an Echocardiography

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China