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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

TP-01-022

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18+ Years
All Sexes

Trial Timing

Ended 11 years ago

What is this trial 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.

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:

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