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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT02173860
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years
* Severe heart valve disease with indication for an elective cardiac with a St. Jude Medical Heart Valve
* Concomitant significant CAD (at least one epicardial vessel with a stenosis\> 50%)
* Willing and able to provide informed written consent
Exclusion Criteria:
* Previous CABG
* Angiographic significant lesion involving left main lesion (patient is still eligible if right coronary artery is candidate for FFR measurement and surgical revascularization)
* All lesions in extremely tortuous or calcified coronary vessels
* Recent myocardial infarction (\< 30 days)
* Cardiogenic shock or clinical instability (i.e. NYHA 4, uncontrolled arrhythmias, unexplained hypotension severe bradycardia or any other medical condition considered as a sign of instability by the assisting physician)
* Severe left ventricular dysfunction (EF \< 35%)
* Pregnant or are planning to become pregnant during the duration of the investigation
* Chronic renal dysfunction as defined as estimated glomerular filtration rate \< 60 ml/min
* Life expectancy \< 12 months
* Currently participating in any other clinical investigation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02173860
Study Brief:
Protocol Section:
NCT02173860