HAART Model 300 Annuloplasty Ring

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 safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking 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. Therefore, potentially aortic valve repair is a good option for patients with AR or AI.

Official Title
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A Prospective, Non-randomized, Multi-center Trial to Evaluate the Safety and Effectiveness of the HAART Model 300 Annuloplasty Ring When Used to Surgically Repair a Leaking Aortic Valve Using a 3-D Intra-annular Mounting Frame

Conditions
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Aortic Regurgitation

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: The subject is 50 years old or older The subject has a tricuspid aortic valve morphology Patients with documented severe aortic insufficiency with aortic annular dilation without severe concomitant aortic stenosis Patients referred to center for documented moderate to severe Chronic aortic regurgitation (AR) associated with annular dilatation with or without cusp prolapse of one, two, or all three leaflets Patients with or without Sinotubular Junction (STJ) dilatation or aortic root aneurysms Patients who are free of coronary disease or those with evidence of minor stable (1-2 vessel) coronary disease Subject is willing to comply with specified follow-up evaluations, including transesophageal echocardiography if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve The subject has signed the written informed consent The subject agrees to return for all follow-up evaluations for the duration of the study (i.e. geographically stable The subject is New York Hospital Association (NYHA) class II or III Exclusion Criteria: The subject has preexisting valve prosthesis in the atrial, the mitral, pulmonary, and/or tricuspid position The subject requires an additional valve replacement The subject's aortic valve morphology is not tricuspid The subject has active endocarditis Heavily calcified valves Valvular retraction with severely reduced mobility The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis The subject requires a repair of the mitral or tricuspid valve with the use of an annuloplasty device 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 Non elective presentation Low Ejection Fraction (EF) EF < 40% Life expectancy < 1 year Rheumatic disease The subject has severe leaflet fenestration or leaflets damaged by endocarditis 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 This patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up The subject has not signed and dated the study informed consent Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA) Myocardial infarction (MI) within one month of trial inclusion Have a known intolerance to titanium or polyester Sole therapy for correction for patients with aortic root aneurysm Subjects requiring simultaneous cardiac procedures The subject has asymptomatic AR and a left ventricular ejection fraction (LVEF) > 50%

Ages Eligible for Study
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Minimum Age: 50 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 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: Event-free Survival | Event-free survival is defined as survival free from device-related death | 1 month postprocedure | 
| Primary Safety Outcome Measure: Event-free Survival | Event-free survival is defined as survival free from device-related death | 2 years postprocedure (extended follow-up) | 
| Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure | Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+) | 6 months postprocedure | 
| Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure | Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+) | 2 years postprocedure (extended follow-up) | 

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 Paravalvular leak > +2 or requiring intervention 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 | 
| 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 Paravalvular leak > +2 or requiring intervention 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. | 2 years postprocedure (extended follow-up) | 
| Actuarial Freedom From Clinical Cardiovascular Events | Freedom from specified clinical cardiovascular events 1 month 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 1 month | 1 month postprocedure | 
| Actuarial Freedom From Clinical Cardiovascular Events | Freedom from specified clinical cardiovascular events 2 years 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 2 years | 2 years postprocedure | 
| Event-free Survival | Event-free survival is defined as survival free from device-related death | 6 months postprocedure | 
| New York Heart Association (NYHA) Functional Capacity Classification | 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 postprocedure | 
| New York Heart Association (NYHA) Functional Capacity Classification | 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 postprocedure (extended follow-up) | 
| Peak Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline, 6 months postprocedure | 
| Peak Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline, 2 years postprocedure (extended follow-up) | 
| Mean Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline, 6 months postprocedure | 
| Mean Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline, 2 years postprocedure (extended follow-up) | 
| LV Mass - Change From Baseline | Left ventricular mass. Transthoracic echocardiography parameter. | Baseline, 6 months postprocedure | 
| LV Mass - Change From Baseline | Left ventricular mass. Transthoracic echocardiography parameter. | Baseline, 2 years postprocedure (extended follow-up) | 
| LVID Diastole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Baseline, 6 months postprocedure | 
| LVID Diastole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Baseline, 2 years postprocedure (extended follow-up) | 
| LVID Systole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Baseline, 6 months postprocedure | 
| LVID Systole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Baseline, 2 years postprocedure (extended follow-up) | 
| LV Diastolic Volume - Change From Baseline | Left ventricular diastolic volume. Transthoracic echocardiography parameter. | Baseline, 6 months postprocedure | 
| LV Diastolic Volume - Change From Baseline | Left ventricular diastolic volume. Transthoracic echocardiography parameter. | Baseline, 2 years postprocedure (extended follow-up) | 
| LV Systolic Volume - Change From Baseline | Left ventricular systolic volume. Transthoracic echocardiography parameter. | Baseline, 6 months postprocedure | 
| LV Systolic Volume - Change From Baseline | Left ventricular systolic volume. Transthoracic echocardiography parameter. | Baseline, 2 years postprocedure (extended follow-up) | 
| LVEF - Change From Baseline | Left ventricular ejection fraction. Transthoracic echocardiography parameter. | Baseline, 6 months postprocedure | 
| LVEF - Change From Baseline | Left ventricular ejection fraction. Transthoracic echocardiography parameter. | Baseline, 2 years postprocedure (extended follow-up) | 
| Cardiac Output - Change From Baseline | Stroke volume x heart rate. Transthoracic echocardiography parameter. | Baseline, 6 months postprocedure | 
| Cardiac Output - Change From Baseline | Stroke volume x heart rate. Transthoracic echocardiography parameter. | Baseline, 2 years postprocedure (extended follow-up) | 
| Cardiac Index - Change From Baseline | Hemodynamic parameter computed as cardiac output divided by body surface area | Baseline, 6 months postprocedure | 
| Cardiac Index - Change From Baseline | Hemodynamic parameter computed as cardiac output divided by body surface area | Baseline, 2 years postprocedure (extended follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Repair