N/A
Completed N=225
A Retrospective Study to Collect the Data From the Patients Who Had the Perimount Heart Valve Replacement Surgery in China During 2001 to 2007
Mitral Valve or Aortic Valve Replacement
Source: ClinicalTrials.gov NCT02381678 ↗
Enrolled (actual)
225
Serious AEs
41.8%
Results posted
Oct 2016
Primary outcomePrimary: The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography — 100; 54.54; 26.51; 81.33 Percentage of all subjects
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography |
100; 54.54; 26.51; 81.33; 62.41; 51.63 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02381678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.