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
• Interventions: Device: Perimount 2900/6900 Heart Valve

• 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

Arm && Interventions

Group	Intervention	Description
Subjects implanted with Perimount Heart Valve	Perimount 2900/6900 Heart Valve	Only one group was set for this study, including all enrolled subjects who implanted with Perimount Heart Valve during 2001 to 2007

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