The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance

Study Overview
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Brief Summary
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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
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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.

Official Title
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The HAART 300 Annuloplasty Ring Extended Safety and Performance Trial Used in Surgical Repair of the Aortic Valve

Conditions
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Aortic Insufficiency

Intervention / Treatment
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* Device: HAART 300 Annuloplasty Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HAART 300 Annuloplasty Device<br>Implantation of HAART 300 Annuloplasty Device for aortic valve repair | Device: HAART 300 Annuloplasty Device<br>* Implantation of HAART 300 Annuloplasty Device for aortic valve repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure |  | 6 months | 
| Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months | Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Procedure Success | Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability. | discharge or 14 days postprocedure, whichever comes first | 
| Actuarial Freedom From Clinical Cardiovascular Events | Freedom from specified clinical cardiovascular events at 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months | 6 months | 
| Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure |  | 2 years | 
| Aortic Insufficiency (AI) at 2 Years | Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+) | 2 years | 
| New York Heart Association (NYHA) Functional Capacity Classification at 6 Months | Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort | 6 months | 
| New York Heart Association (NYHA) Functional Capacity Classification at 2 Years | Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort | 2 years | 
| Peak Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline and 6 months | 
| Peak Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline and 2 years | 
| Mean Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline and 6 months | 
| Mean Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline and 2 years | 
| LV Mass - Change From Baseline | Left ventricular mass. Transthoracic echocardiography parameter. | Baseline and 6 months | 
| LV Mass - Change From Baseline | Left ventricular mass. Transthoracic echocardiography parameter. | Baseline and 2 years | 
| LVID Diastole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Baseline and 6 months | 
| LVID Diastole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Baseline and 2 years | 
| LVID Systole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Baseline and 6 months | 
| LVID Systole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Baseline and 2 years | 
| LV Diastolic Volume - Change From Baseline | Left ventricular diastolic volume. Transthoracic echocardiography parameter. | Baseline and 6 months | 
| LV Diastolic Volume - Change From Baseline | Left ventricular diastolic volume. Transthoracic echocardiography parameter. | Baseline and 2 years | 
| LV Systolic Volume - Change From Baseline | Left ventricular systolic volume. Transthoracic echocardiography parameter. | Baseline and 6 months | 
| LV Systolic Volume - Change From Baseline | Left ventricular systolic volume. Transthoracic echocardiography parameter. | Baseline and 2 years | 
| LVEF - Change From Baseline | Left ventricular ejection fraction. Transthoracic echocardiography parameter. | Baseline and 6 months | 
| LVEF - Change From Baseline | Left ventricular ejection fraction. Transthoracic echocardiography parameter. | Baseline and 2 years | 
| Cardiac Output - Change From Baseline | Stroke volume x heart rate. Transthoracic echocardiography parameter. | Baseline and 6 months | 
| Cardiac Output - Change From Baseline | Stroke volume x heart rate. Transthoracic echocardiography parameter. | Baseline and 2 years | 
| Cardiac Index - Change From Baseline | Hemodynamic parameter computed as cardiac output divided by body surface area | Baseline and 6 months | 
| Cardiac Index - Change From Baseline | Hemodynamic parameter computed as cardiac output divided by body surface area | Baseline and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Insufficiency (AI) Aortic Regurgitation (AR)