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 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT01727167
Eligibility Criteria:
Inclusion Criteria:
1. Able to consent
2. Competent adult
3. Scheduled to undergo aortic or mitral valve surgery only, not combined valve / revascularization procedures.
Exclusion Criteria:
1. Unable to consent
2. Tobacco use
3. Unanticipated medical diagnoses made at the time of surgery which require further procedures lengthening OR time and complexity above that of AVR alone.
4. Concomitant coronary artery disease.
5. Renal dialysis
6. Hemodynamic instability
7. End stage COPD defined as requiring home oxygen
8. By history any significant exposure to second hand smoke including living with a smoker who smokes indoors or working in a high smoking environment for 8 hours a day or more (i.e. factory or bar) will exclude subject from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01727167
Study Brief:
Protocol Section:
NCT01727167