The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance

BioStable Science & Engineering

Status

Completed

Conditions

Aortic Insufficiency

Treatments

Device: HAART 300 Annuloplasty Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT01732835

TP-01-022

Details and patient eligibility

About

This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D intra-annular mounting frame.

Full description

Aortic Regurgitation, (also known as Aortic Insufficiency; AI), is the failure of the aortic valve to close completely during diastole which causes blood to flow from the aorta back into the left ventricle. Aortic Regurgitation (AR) is a frequent cause of both disability and death due to congestive heart failure, primarily in individuals forty or older, but can also occur in younger populations.

Traditionally management of aortic regurgitation has been by aortic valve replacement, however, as has been observed in patients who have had mitral valve repair, the option of maintaining ones native aortic valve versus a replacement, either bioprosthetic or mechanical, can have added multiple benefits. The advantage of repair is the avoidance of prosthetic valve-related complications with bioprosthetic valves over 10-15 years or the need for anticoagulation with mechanical valves and the related problems of this therapy.

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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