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:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT01732835
Eligibility Criteria:
Inclusion Criteria:
* Subject is 18 years of age or older
* Subject has tri-leaflet aortic valve morphology
* Subject has documented aortic valve disease which may or may not include:
1. aortic valve insufficiency
2. aortic root pathology
3. pathology of the ascending aorta
4. patients with associated stable one or two vessel coronary disease requiring concomitant coronary bypass
* Subject is willing to comply with specified follow-up evaluations, including transesophageal echocardiography (TEE) if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve
* Subject has reviewed and signed the written informed consent form
* Subject agrees to return for all follow-up evaluations for the duration of the study (i.e.,. geographically stable)
Exclusion Criteria:
* The subject has pre-existing valve prosthesis in the aortic position
* The subject's aortic valve morphology is not tri-leaflet
* The subject has active endocarditis
* Heavily calcified valves
* The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis
* Leukopenia
* Acute anemia (Hb \< 9mg%)
* Platelet count \<100,000 cell/mm3
* Need for emergency surgery for any reason
* History of bleeding diathesis or coagulopathy or the subject refuses blood transfusions
* Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 4 weeks after discontinuation of antibiotics)
* Subjects in whom transesophageal echocardiography (TEE) is contraindicated
* Low Ejection Fraction (EF) EF \< 35%
* Life expectancy \< 1 year
* The subject is or will be participating in a concomitant research study of an investigational product or has participated in such a study within the 30 days prior to screening
* The subject is a minor, an illicit drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
* The subject is pregnant or lactating
* Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
* Myocardial Infarction (MI) within one month of trial inclusion
* The subject has a known intolerance to titanium or polyester
* The subject has documented unstable or \> 2 vessel coronary disease
* The subject requires additional valve replacement or valve repair
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01732835
Study Brief:
Protocol Section:
NCT01732835