HAART Model 300 Annuloplasty Ring

This is an interventional treatment trial for Aortic Regurgitation focused on measuring Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Repair Read More

Inclusion Criteria:

• The subject is 50 years old or older
• The subject has a tricuspid aortic valve morphology
• Patients with documented severe aortic insufficiency with aortic annular dilation without severe concomitant aortic stenosis
• Patients referred to center for documented moderate to severe Chronic aortic regurgitation (AR) associated with annular dilatation with or without cusp prolapse of one, two, or all three leaflets
• Patients with or without Sinotubular Junction (STJ) dilatation or aortic root aneurysms
• Patients who are free of coronary disease or those with evidence of minor stable (1-2 vessel) coronary disease
• Subject is willing to comply with specified follow-up evaluations, including transesophageal echocardiography if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve
• The subject has signed the written informed consent
• The subject agrees to return for all follow-up evaluations for the duration of the study (i.e. geographically stable
• The subject is New York Hospital Association (NYHA) class II or III

Exclusion Criteria:

• The subject has preexisting valve prosthesis in the atrial, the mitral, pulmonary, and/or tricuspid position
• The subject requires an additional valve replacement
• The subject's aortic valve morphology is not tricuspid
• The subject has active endocarditis
• Heavily calcified valves
• Valvular retraction with severely reduced mobility
• The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis
• The subject requires a repair of the mitral or tricuspid valve with the use of an annuloplasty device
• 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
• Non elective presentation
• Low Ejection Fraction (EF) EF < 40%
• Life expectancy < 1 year
• Rheumatic disease
• The subject has severe leaflet fenestration or leaflets damaged by endocarditis
• 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
• This patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up
• The subject has not signed and dated the study informed consent
• Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
• Myocardial infarction (MI) within one month of trial inclusion
• Have a known intolerance to titanium or polyester
• Sole therapy for correction for patients with aortic root aneurysm
• Subjects requiring simultaneous cardiac procedures
• The subject has asymptomatic AR and a left ventricular ejection fraction (LVEF) > 50%