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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT01514994
Eligibility Criteria:
Inclusion Criteria:
* Native, degenerative-calcific, tricuspid, aortic valve stenosis with echocardiographic derived criteria: mean gradient of \>40 mm Hg or Doppler peak systolic velocity greater than 4.0 m/s or an initial aortic valve area \< 0.8 cm2.
* Symptomatic aortic valve disease as demonstrated by CCS Functional Class II or greater
* Aortic valve annulus of greater than or equal to 18 mm and less than or equal to 28 mm measured on pre-procedure TTE.
* Phase 1 patients must be scheduled for a surgical aortic valve replacement.
* Phase 2 patients must not be suitable candidates for elective surgical aortic valve replacement.
Exclusion Criteria:
* Recent myocardial infarction (\<30days)
* Unicuspid or bicuspid aortic valve or non-calcific aortic valve stenosis
* Any sepsis, including active endocarditis
* Concomitant 2+ or greater aortic valve valve regurgitation
* LVEF \< 20%
* CVA or TIA within the previous 6 months
* Previous aortic valve replacement (bioprosthetic or mechanical)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01514994
Study Brief:
Protocol Section:
NCT01514994