Table 9

Patient Selection: Inclusion and Exclusion Criteria in Clinical Trials

Inclusion Criteria
  • 1. Patient has calcific aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mm Hg or jet velocity >4.0 m/s and an initial AVA of <0.8 cm2 or indexed EOA <0.5 cm2/m2. Qualifying AVA baseline measurement must be within 45 days of the date of the procedure.

  • 2. A cardiac interventionalist and 2 experienced cardiothoracic surgeons agree that medical factors either preclude operation or are high risk for surgical AVR, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. The surgeons' consult notes shall specify the medical or anatomic factors leading to that conclusion and include a printout of the calculation of the STS score to additionally identify the risks in the patient. At least 1 of the cardiac surgeon assessors must have physically evaluated the patient.

  • 3. Patient is deemed to be symptomatic from his/her aortic valve stenosis, as differentiated from symptoms related to comorbid conditions, and as demonstrated by NYHA functional class II or greater.

Exclusion Criteria (candidates will be excluded if any of the following conditions are present)
  •  1 Evidence of an acute myocardial infarction ≤1 month (30 days) before the intended treatment (defined as: Q-wave MI, or non–Q-wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation [WHO definition])

  •  2 Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is noncalcified

  •  3 Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+)

  •  4 Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of screening evaluation

  •  5 Need for emergency surgery for any reason

  •  6 Hypertrophic cardiomyopathy with or without obstruction

  •  7 Severe left ventricular dysfunction with LVEF <20%

  •  8 Severe pulmonary hypertension and RV dysfunction

  •  9 Echocardiographic evidence of intracardiac mass, thrombus or vegetation

  •  10 A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure

  •  11 Native aortic annulus size <18 mm or >25 mm as measured by echocardiogram

  •  12 MRI confirmed CVA or TIA within 6 months (180 days) of the procedure

  •  13 Renal insufficiency (creatinine >3.0 mg/dL) and/or end-stage renal disease requiring chronic dialysis at the time of screening

  •  14 Estimated life expectancy <12 months (365 days) due to noncardiac comorbid conditions

  •  15 Severe incapacitating dementia

  •  16 Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5 cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (>5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe “unfolding” and tortuosity of the thoracic aorta

  •  17 Severe mitral regurgitation

AVA indicates aortic valve area; AVR, aortic valve replacement; CK, creatine kinase; CVA, cerebrovascular accident; EOA, effective orifice area; LVEF, left ventricular ejection fraction; MB, MB isoenzyme; MI, myocardial infarction; MRI, magnetic resonance imaging; NYHA, New York Heart Association; RV, right ventricular; STS, Society of Thoracic Surgeons; TIA, transient ischemic attack; and WHO, World Health Organization.

  • The boundaries of annulus size will continue to change in concert with changing device size.