CompletedNot Applicable

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

China225 participantsStarted 2014-05

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography

Timeframe: 7-15 years after heart valve replacement surgery (during 2001-2007)

Trial details

NCT IDNCT02381678

SponsorEdwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-11

Results submitted2016-05-26

View on ClinicalTrials.gov More Mitral Valve or Aortic Valve Replacement trials