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Clinical Trials/NCT02400489
NCT02400489
Completed
Not Applicable

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

Edwards Lifesciences3 sites in 1 country265 target enrollmentSeptember 25, 2014
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ConditionsMitral Valve or Aortic Valve Replacement

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mitral Valve or Aortic Valve Replacement
Sponsor
Edwards Lifesciences
Enrollment
265
Locations
3
Primary Endpoint
Twice echocardiography to evaluate the performance of heart valve
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 25, 2014
End Date
June 3, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Edwards Lifesciences
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

The recovery status of patients after surgery

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

Study Sites (3)

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