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OpenTrials
Completed

NCT Number: NCT02400489

Clinical Study to Evaluate the Performance of Perimount Heart Valve in Chinese Patients

To recruit patients who implanted with Perimount Heart Valve (Type Number: 6900PTFX or 2800TFX) from three hospitals in China.

To track the patients'situations during one year after surgery and to collect the relevant clinical data.

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Key information

Conditions

Mitral Valve or Aortic Valve Replacement

Sex eligibility

All sexes

Study type

Observational

Primary location

Wuhan Asia Heart Hospital, Wuhan, Hubei, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients implanted with Perimount 6900PTFX after 2012-11-19 or with Perimount 2800TFX after 2013-8-20
  • Patients sign the Inform Consent Form (ICF) and agree to join the study

Exclusion criteria

  • Don't have any specific exclusion criteria.

Treatment and study plan

Primary outcomes

  1. Twice echocardiography to evaluate the performance of heart valve

    Time frame: Compare the 1st echocardiography at average 6 months after surgery and 2nd echocardiography at 12 months after surgery

    subjects need to do the echocardiography in two follow up visits

  2. The recovery status of patients after surgery

    Time frame: The subjects will be followed for the duration of one year after surgery

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2020
First posted
Mar 27, 2015
Registry last updated
Mar 18, 2022

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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