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:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT02122900
Eligibility Criteria:
Inclusion criteria:
Patients will be identified in the valve clinics and from the cath lab schedules. All patients who are scheduled to have a BAV during the study period in the cath lab at MCD and THHBP for whom a definitive pre-procedure BAV indication including the following will be eligible for enrollment:
* BAV as palliation
* BAV offered as a means of assessment for a change to operable status (a 'bridge' to decision). Patients in this category will be classified by the procedure physician as to the primary reason of 'bridge' decision - these reasons would include:
* Diagnostic
* Shortness of Breath- Aortic stenosis vs. other etiology such as COPD
* Lack of Energy- Aortic stenosis vs. other etiology
* LV Dysfunction - Aortic stenosis vs. cardiomyopathy
* Therapeutic- determination of improvement to receive treatment
* Frailty - Factors: grip strength, 5 meter walk time, Katz Index of Independence in Activities of Daily Living (Katz ADL), serum Albumin
* Immobility - Reason for immobility and current assistive device will be documented
* Stage IV chronic kidney disease - Cockoft- Gault formula (GRF 15-29 mL/min/1.73 m2) or high procedural risk for progression to dialysis dependence
* End stage renal disease currently on dialysis Acute kidney Injury - (Varc 2)
* Severe left ventricular dysfunction - BAV to improve EF (VARC 2) LVEF \< 35% without contractile reserve
* NYHA class IV congestive heart failure
* Active bleeding
* Urgent or emergent clinical status
* Severe liver disease (VARC 2)
* Active Infection
* Other cause:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
The Kansas City Cardiomyopathy questionnaire (KCCQ), a quality of life (QOL) assessment, and the Connor-Davidson 10 Resilience Scale will be collected from all patients for whom informed consent is obtained by the study coordinators to administer the QOL assessment and resilience scale.
Exclusion Criteria:
* None
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02122900
Study Brief:
Protocol Section:
NCT02122900