Clinical Study to Evaluate the Performance of Perimount Heart Valve in Chinese Patients
Completed
- Conditions
- Mitral Valve or Aortic Valve Replacement
- Registration Number
- NCT02400489
- Lead Sponsor
- Edwards Lifesciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 265
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Twice echocardiography to evaluate the performance of heart valve 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 The subjects will be followed for the duration of one year after surgery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Wuhan Asia Heart Hospital
🇨🇳Wuhan, Hubei, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Tianjin Chest Hospital
🇨🇳Tianjin, Tianjin, China