HAART 200 Aortic Valve Annuloplasty Trial
HAART 200 Aortic Valve Annuloplasty Trial
The HAART 200 "Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction" Trial is a
 prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of
 the HAART 200 bicuspid annuloplasty ring when used to surgically stabilize the aortic valve
 annulus in patients undergoing repair of bicuspid aortic valves (BAV) for predominant aortic
 insufficiency (AI).
Aortic valve disease is the most common valvular heart disease with approximately 200,000
 patients per year undergoing conventional aortic valve replacement in North America and
 Europe. Around 60% of valves have Aortic Stenosis (AS) and 40% of have Aortic Insufficiency,
 which is the failure of the aortic valve to close completely during diastole, causing blood
 to flow from the aorta back into the left ventricle. Bicuspid valve morphology is present in
 a fourth to a third of patients coming to surgical intervention, and constitutes a very
 important subset. Several conditions are associated with bicuspid disease, including
 ascending aortic or root aneurysms in up to a third.

 Traditional management of aortic valve and root disease has been with aortic valve
 replacement, with or without root replacement (Bentall Procedure). However, as has been
 observed in patients with mitral valve repair, the option of maintaining one's reconstructed
 native valve versus a replacement, either bioprosthetic or mechanical, can have multiple
 benefits. The advantages of repair include: the avoidance of prosthetic valve related
 complications and structural degeneration with bioprosthetic valves over 10-15 years and
 elimination of the need for anticoagulation and related problems with mechanical valves in
 younger patients. The significantly lower rate of endocarditis after repair is a major
 impetus to increasing performance of BAV reconstruction. Thus, aortic valve repair currently
 is established as an excellent option for patients with BAV. However, with connective tissue
 disorders being an inherent feature of BAV, outcomes have been less stable long-term than for
 trileaflet repair, primarily because of late annular redilatation in BAV disease.

 Therefore, this study is designed to evaluate the safety and effectiveness of annular
 stabilization with a bicuspid annuloplasty ring in patients undergoing repair of a bicuspid
 aortic valve for predominant aortic insufficiency.
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