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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT03881527
Eligibility Criteria:
Inclusion Criteria:
* Severe aortic stenosis defined as one or more of the following by Doppler echocardiography: mean gradient \>40 mmHg; max velocity \>4 m/sec; aortic valve area \<=0.8 cm2.
* Symptoms related to aortic valve disease, and NYHA Functional Class II or greater
* Subject is indicated for aortic valve implantation with a biological prosthesis (tissue valve)
* Age \>= 65 years
* Echocardiographically determined aortic annulus diameter \>=24 mm and \<=30 mm in a long-axis view
* Subject understands the implications of participating in the study and provides informed consent
Exclusion Criteria:
* Congenital unicuspid aortic valve
* Severe eccentricity of calcification, defined as calcium deposits larger than 6 mm in diameter
* Echocardiographic evidence of intracardiac mass, thrombus or vegetation
* Left ventricular ejection fraction \<25% as determined by contrast ventriculography, or echocardiography or radionuclide angiography if contrast ventriculography not available
* Hypertrophic obstructive cardiomyopathy
* Subjects with life expectancy less than 12 months due to an underlying non-cardiac co-morbid disease
* Known hypersensitivity or contraindication that cannot be adequately controlled with pre-medication to any study medication or material, such as contrast medium or Nitinol
* Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy
* Renal insufficiency assessed by creatinine \>2.5 mg/dl and/or end stage renal disease requiring chronic dialysis
* Poor lung function that in the investigator's opinion is prohibitive for thoracotomy
* Active peptic ulcer or GI bleeding within 3 months from the planned index procedure
* Cardiogenic shock, suspected cardiogenic shock, or hemodynamic instability requiring inotropic support or mechanical heart assistance
* Peripheral vascular disease, including abdominal and thoracic aortic disease, that could pose a problem for eventual transarterial mechanical support (e.g. intraaortic balloon pump)
* History of myocardial infarction in the last 6 weeks
* History of TIA or CVA in the last 6 months
* Subject refuses to have a blood transfusion
* Subject is currently enrolled in another investigational device or drug trial that may influence the outcome of this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT03881527
Study Brief:
Protocol Section:
NCT03881527