CompletedNot Applicable

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

China265 participantsStarted 2014-09-25

Plain-language summary

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.

Who can participate

SexALL

See this in plain English?

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

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.

What they're measuring

Twice echocardiography to evaluate the performance of heart valve

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

The recovery status of patients after surgery

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

Trial details

NCT IDNCT02400489

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-04-27

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