Status:
COMPLETED
Observational Study of Prosthetic Tissue Aortic and Mitral Heart Valve
Lead Sponsor:
Abbott Medical Devices
Conditions:
Valvular Heart Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a multi-center, prospective, non-randomized, observational study. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic valve.
Detailed Description
This study is a multi-centered, multi-country, prospective, non-randomized, observational study, without concurrent or matched controls, conducted under a common protocol. Bayesian methods will be use...
Eligibility Criteria
Inclusion
- The patient requires replacement of the aortic and/or mitral valve (Note: Patients undergoing concomitant procedures, e.g. coronary artery bypass grafting, valve repair, are eligible for this study).
- The patient (or legal guardian) 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
- Patient already has a prosthetic valve, other than the aortic and/or mitral valve being replaced at this time.
- The patient requires replacement of the tricuspid or pulmonary valve.
- The patient is pregnant or nursing.
- Patient has active endocarditis.
- Patient is actively participating in the study of an investigational drug or device.
- Patient has had an acute preoperative neurological event.
- The patient is undergoing renal dialysis.
- Patient is an intravenous drug abuser, alcohol abuser or prison inmate.
- Patient has an inability or unwillingness to return for the required follow-up intervals.
- The patient had the SJM Epic Valve implanted during the clinical study but then had the bioprosthesis explanted.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
761 Patients enrolled
Trial Details
Trial ID
NCT00329667
Start Date
January 1 2003
End Date
September 1 2008
Last Update
February 4 2019
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