The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
Sponsored by Biostable Science & Engineering
About this trial
Last updated 9 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 11 years ago
What is this trial about?
What are the participation requirements?
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:
* 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
