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Completed

NCT Number: NCT02381678

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

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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Key information

Conditions

Mitral Valve or Aortic Valve Replacement

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangdong General Hospital

Guangzhou, Guangdong, 510120, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perimount 2900/6900 Heart Valve

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.

Primary outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 6, 2015
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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