The HAART 300 Annuloplasty Ring Extended Safety and Performance Trial Used in Surgical Repair of the Aortic Valve

Inclusion Criteria:

• Subject is 18 years of age or older
• Subject has tri-leaflet aortic valve morphology

• Subject has documented aortic valve disease which may or may not include:

  1. aortic valve insufficiency
  2. aortic root pathology
  3. pathology of the ascending aorta
  4. patients with associated stable one or two vessel coronary disease requiring concomitant coronary bypass
• Subject is willing to comply with specified follow-up evaluations, including transesophageal echocardiography (TEE) if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve
• Subject has reviewed and signed the written informed consent form
• Subject agrees to return for all follow-up evaluations for the duration of the study (i.e.,. geographically stable)

Exclusion Criteria:

• The subject has pre-existing valve prosthesis in the aortic position
• The subject's aortic valve morphology is not tri-leaflet
• The subject has active endocarditis
• Heavily calcified valves
• The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis
• Leukopenia
• Acute anemia (Hb < 9mg%)
• Platelet count <100,000 cell/mm3
• Need for emergency surgery for any reason
• History of bleeding diathesis or coagulopathy or the subject refuses blood transfusions
• Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 4 weeks after discontinuation of antibiotics)
• Subjects in whom transesophageal echocardiography (TEE) is contraindicated
• Low Ejection Fraction (EF) EF < 35%
• Life expectancy < 1 year
• The subject is or will be participating in a concomitant research study of an investigational product or has participated in such a study within the 30 days prior to screening
• The subject is a minor, an illicit drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
• The subject is pregnant or lactating
• Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
• Myocardial Infarction (MI) within one month of trial inclusion
• The subject has a known intolerance to titanium or polyester
• The subject has documented unstable or > 2 vessel coronary disease
• The subject requires additional valve replacement or valve repair