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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT00475267
Eligibility Criteria:
Inclusion Criteria:
* Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time).
* Legal age.
* Signed informed consent prior to surgery.
* Willing to complete all follow-up requirements.
Exclusion Criteria:
* Pregnant or nursing women.
* Have already had a valve replaced other than the aortic valve.
* Needs another valve replaced.
* Cannot return for required follow-up visits.
* Have active endocarditis.
* Acute preoperative neurological event (such as a stroke).
* Renal dialysis.
* History of substance abuse within one year, or a prison inmate.
* Participating in another study.
* Life expectancy less than two years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00475267
Study Brief:
Protocol Section:
NCT00475267