The HAART 300 Annuloplasty Ring Extended Safety and Performance Trial Used in Surgical Repair of the Aortic Valve
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 68
- Locations
- 8
- Primary Endpoint
- Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •aortic valve insufficiency
- •aortic root pathology
- •pathology of the ascending aorta
- •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
Arms & Interventions
HAART 300 Annuloplasty Device
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Intervention: HAART 300 Annuloplasty Device (Device)
Outcomes
Primary Outcomes
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months
Time Frame: 6 months
Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure
Time Frame: 6 months
Secondary Outcomes
- LV Diastolic Volume - Change From Baseline(Baseline and 2 years)
- Actuarial Freedom From Clinical Cardiovascular Events(6 months)
- New York Heart Association (NYHA) Functional Capacity Classification at 2 Years(2 years)
- Implant Procedure Success(discharge or 14 days postprocedure, whichever comes first)
- Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure(2 years)
- Aortic Insufficiency (AI) at 2 Years(2 years)
- New York Heart Association (NYHA) Functional Capacity Classification at 6 Months(6 months)
- Mean Gradient - Change From Baseline(Baseline and 2 years)
- Cardiac Output - Change From Baseline(Baseline and 2 years)
- LVID Systole - Change From Baseline(Baseline and 2 years)
- LV Systolic Volume - Change From Baseline(Baseline and 2 years)
- LVID Diastole - Change From Baseline(Baseline and 2 years)
- Peak Gradient - Change From Baseline(Baseline and 2 years)
- LV Mass - Change From Baseline(Baseline and 2 years)
- LVEF - Change From Baseline(Baseline and 2 years)
- Cardiac Index - Change From Baseline(Baseline and 2 years)
- Peak Gradient - Change From Baseline(Baseline and 6 months)
- Mean Gradient - Change From Baseline(Baseline and 6 months)
- LV Mass - Change From Baseline(Baseline and 6 months)
- LVID Diastole - Change From Baseline(Baseline and 6 months)
- LVID Systole - Change From Baseline(Baseline and 6 months)
- LV Diastolic Volume - Change From Baseline(Baseline and 6 months)
- LV Systolic Volume - Change From Baseline(Baseline and 6 months)
- LVEF - Change From Baseline(Baseline and 6 months)
- Cardiac Output - Change From Baseline(Baseline and 6 months)
- Cardiac Index - Change From Baseline(Baseline and 6 months)