Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT00329667
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00329667
Study Brief:
Protocol Section:
NCT00329667