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 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT01060020
Eligibility Criteria:
Inclusion Criteria:
* Severe aortic stenosis (AVA \< 1.0 cm2)
* Referred for a clinically ordered right and left heart catheterization
* 18 years of age and older
* Able and willing to comply with all requirements of the study
Exclusion Criteria:
* Nitrate use within 24 hours
* SBP \< 110 mmHg or MAP \< 75 mmHg
* Severe mitral regurgitation
* Severe aortic regurgitation
* Increased risk of priapism
* Retinal or optic nerve problems or unexplained visual disturbance
* Alpha antagonists or cytochrome P450 3A4 inhibitors use within 24 hours
* Current or recent (≤ 30 days) acute coronary syndrome
* O2 sat \< 90% on room air
* Females that are pregnant or believe they may be pregnant
* Any condition which the PI determines will place the subject at increased risk or is likely to yield unreliable hemodynamic data
* Unwilling to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01060020
Study Brief:
Protocol Section:
NCT01060020