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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Mitral Valve or Aortic Valve Replacement

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subjects implanted with Perimount Heart Valve

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

Perimount 2900/6900 Heart Valve

Intervention Type DEVICE

This is a retrospective study which ask the subjects implanted with Perimount Heart Valve during 2001 to 2007 back hospital for follow up visit.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No