An Observational, Prospective Evaluation of the St Jude Medical Epic Valve
Not Applicable
Completed
- Conditions
- Structural Valve Deterioration (SVD)Central regurgitationcalcification of the valveThrombus or Pannus formationCardiovascular - Diseases of the vasculature and circulation including the lymphatic systemCardiovascular - Coronary heart disease
- Registration Number
- ACTRN12610000023055
- Lead Sponsor
- St. Jude Medical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
The patient requires replacement of the aortic and/or mitral valve
-The patient has signed a study specific informed consent agreeing to the data collection and follow-up requirements
- The patient is of legal age in host country
Exclusion Criteria
- Patient already has a prosthetic valve, other than an aortic and/or mitral valve being replaced at this occasion
- Patient requries replacement of tricuspid valve or pulmonary valve
- The Patient is pregnant
- The patient has acticve endocarditis
- Patient is undergoing renal dialysis
- The patient has had an acute preoperative neurological event
- the paitient is an intravenous drug abuser, alcoholic or prison inmate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to confirm the clinical safety and efficacy of the SJM Epic valve.<br><br>This will be assessed through the collection of: Blood tests and Echocardiograms.[12 months post implant of SJM Epic valve]
- Secondary Outcome Measures
Name Time Method To monitor clinical adverse effect rates. This will be analysed through the collection of the safety data: histopathology reports, operative notes and physicians reported adverse events. Early rates, linearized rates and Kaplan-Meir life tables for: Hemolysis, non-structural dysfunction, paravalvular leak, structural deterioration/failure, bleeding events, embolism, endocarditis, valve thrombosis, reoperation, explant and death.[12 months post SJM Epic valve implant. Data will be collected at 6months, 12 months and when notified (at time of occurance).];To establish clinical status as indicated by NYHA functional classification[12 months post SJM Epic valve implant];To establish the devices hemodynamic performance through the analysing the Echocardiogram results for the mean gradient, peak gradient, effective orifice area, cardiac output, cardiac index and performance index.[12 months post SJM Epic Valve implant.]