The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance

• Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure [ Time Frame: 6 months ]
  
• 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+)
  
  

• Implant Procedure Success [ Time Frame: discharge or 14 days postprocedure, whichever comes first ]
  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.
  
  
• Actuarial Freedom From Clinical Cardiovascular Events [ Time Frame: 6 months ]
  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
  
  
• Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure [ Time Frame: 2 years ]
  
• Aortic Insufficiency (AI) at 2 Years [ Time Frame: 2 years ]
  Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
  
  
• New York Heart Association (NYHA) Functional Capacity Classification at 6 Months [ Time Frame: 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
  
  
• New York Heart Association (NYHA) Functional Capacity Classification at 2 Years [ Time Frame: 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
  
  
• Peak Gradient - Change From Baseline [ Time Frame: Baseline and 6 months ]
  Transthoracic echocardiography parameter
  
  
• Peak Gradient - Change From Baseline [ Time Frame: Baseline and 2 years ]
  Transthoracic echocardiography parameter
  
  
• Mean Gradient - Change From Baseline [ Time Frame: Baseline and 6 months ]
  Transthoracic echocardiography parameter
  
  
• Mean Gradient - Change From Baseline [ Time Frame: Baseline and 2 years ]
  Transthoracic echocardiography parameter
  
  
• LV Mass - Change From Baseline [ Time Frame: Baseline and 6 months ]
  Left ventricular mass. Transthoracic echocardiography parameter.
  
  
• LV Mass - Change From Baseline [ Time Frame: Baseline and 2 years ]
  Left ventricular mass. Transthoracic echocardiography parameter.
  
  
• LVID Diastole - Change From Baseline [ Time Frame: Baseline and 6 months ]
  Left ventricular internal dimension. Transthoracic echocardiography parameter.
  
  
• LVID Diastole - Change From Baseline [ Time Frame: Baseline and 2 years ]
  Left ventricular internal dimension. Transthoracic echocardiography parameter.
  
  
• LVID Systole - Change From Baseline [ Time Frame: Baseline and 6 months ]
  Left ventricular internal dimension. Transthoracic echocardiography parameter.
  
  
• LVID Systole - Change From Baseline [ Time Frame: Baseline and 2 years ]
  Left ventricular internal dimension. Transthoracic echocardiography parameter.
  
  
• LV Diastolic Volume - Change From Baseline [ Time Frame: Baseline and 6 months ]
  Left ventricular diastolic volume. Transthoracic echocardiography parameter.
  
  
• LV Diastolic Volume - Change From Baseline [ Time Frame: Baseline and 2 years ]
  Left ventricular diastolic volume. Transthoracic echocardiography parameter.
  
  
• LV Systolic Volume - Change From Baseline [ Time Frame: Baseline and 6 months ]
  Left ventricular systolic volume. Transthoracic echocardiography parameter.
  
  
• LV Systolic Volume - Change From Baseline [ Time Frame: Baseline and 2 years ]
  Left ventricular systolic volume. Transthoracic echocardiography parameter.
  
  
• LVEF - Change From Baseline [ Time Frame: Baseline and 6 months ]
  Left ventricular ejection fraction. Transthoracic echocardiography parameter.
  
  
• LVEF - Change From Baseline [ Time Frame: Baseline and 2 years ]
  Left ventricular ejection fraction. Transthoracic echocardiography parameter.
  
  
• Cardiac Output - Change From Baseline [ Time Frame: Baseline and 6 months ]
  Stroke volume x heart rate. Transthoracic echocardiography parameter.
  
  
• Cardiac Output - Change From Baseline [ Time Frame: Baseline and 2 years ]
  Stroke volume x heart rate. Transthoracic echocardiography parameter.
  
  
• Cardiac Index - Change From Baseline [ Time Frame: Baseline and 6 months ]
  Hemodynamic parameter computed as cardiac output divided by body surface area
  
  
• Cardiac Index - Change From Baseline [ Time Frame: Baseline and 2 years ]
  Hemodynamic parameter computed as cardiac output divided by body surface area
  
  

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.