HAART 200 Aortic Valve Annuloplasty Trial

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

Inclusion Criteria:

1. The subject is 18 years of age or older
2. The subject has bi-leaflet aortic valve morphology

3. The subject has documented aortic valve disease which may or may not include:

   • Aortic valve insufficiency
   • Ascending aortic or aortic root pathology
   • Other pathology of the ascending aorta that requires elective aortic replacement
   • Associated stable one or two vessel coronary disease requiring concomitant coronary bypass
   • Patients with recurrent severe AI (Grade 3 or 4) after prior bicuspid repair who are undergoing re-repair because of annular re-dilatation
   • All bicuspid annular and leaflet configurations will be included

4. The subject needs:

   • correction of BAV annular dilatation in patients with chronic AI and dilated annulus
   • restoration of a circular annular shape in patients with bicuspid valve and expansion of sinus to sinus dimensions
   • stabilization of annular geometry long-term in rare bicuspid valve patients with severe AI and minimal annular dilatation
5. The 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
6. The subject has reviewed and signed the written informed consent form
7. The subject agrees to return for all follow-up evaluations for the duration of the study (i.e. geographically stable)

Exclusion Criteria:

1. All patients will be excluded who require emergency surgery for any reason.
2. All the patients who have had a prior heart valve replacement
3. The subject's aortic valve morphology is not bicuspid.
4. The subject has active endocarditis
5. The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis
6. Heavily calcified BAV valves, calcified aortic roots, or "porcelain aortas"
7. Leukopenia with a White Blood Cell (WBC) of less than 3000
8. Acute anemia with a Hgb less than 9mg%
9. Platelet count less than 100,000 cells/mm3
10. History of a defined bleeding diathesis or coagulopathy or the subject refuses blood transfusions
11. Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 2-4 weeks after discontinuation of antibiotics)
12. Subjects in whom transesophageal echocardiography (TEE) is contraindicated
13. Low Ejection Fraction (EF) < 35%
14. Life expectancy < 1 year, or severe comorbidities, such as dialysis or severe Chronic Obstructive Pulmonary Disease (COPD)
15. 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
16. The subject is a minor, an illicit drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
17. The subject is pregnant or lactating
18. Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
19. Myocardial Infarction (MI) within one month of trial inclusion
20. The subject has a known intolerance to titanium or polyester
21. The subject has documented unstable or > 2 vessel coronary disease
22. The subject requires additional valve replacement or valve repair