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

NCT02381678 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 225

Last updated 2016-10-17

Study results available
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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

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.

Sponsors & Collaborators

  • Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Huiming Guo, M.D · Guangdong Provincial People's Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-11-30
Completion
2016-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02381678 on ClinicalTrials.gov