Clinical Trial: HAART 200 Aortic Valve Annuloplasty Trial
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: HAART 200 Aortic Valve Annuloplasty During Bicuspid Aortic Valve Reconstruction Trial
Brief Summary: The HAART 200 "Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction" Trial is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART 200 bicuspid annuloplasty ring when used to surgically stabilize the aortic valve annulus in patients undergoing repair of bicuspid aortic valves (BAV) for predominant aortic insufficiency (AI).
Detailed Summary:
Aortic valve disease is the most common valvular heart disease with approximately 200,000 patients per year undergoing conventional aortic valve replacement in North America and Europe. Around 60% of valves have Aortic Stenosis (AS) and 40% of have Aortic Insufficiency, which is the failure of the aortic valve to close completely during diastole, causing blood to flow from the aorta back into the left ventricle. Bicuspid valve morphology is present in a fourth to a third of patients coming to surgical intervention, and constitutes a very important subset. Several conditions are associated with bicuspid disease, including ascending aortic or root aneurysms in up to a third.
Traditional management of aortic valve and root disease has been with aortic valve replacement, with or without root replacement (Bentall Procedure). However, as has been observed in patients with mitral valve repair, the option of maintaining one's reconstructed native valve versus a replacement, either bioprosthetic or mechanical, can have multiple benefits. The advantages of repair include: the avoidance of prosthetic valve related complications and structural degeneration with bioprosthetic valves over 10-15 years and elimination of the need for anticoagulation and related problems with mechanical valves in younger patients. The significantly lower rate of endocarditis after repair is a major impetus to increasing performance of BAV reconstruction. Thus, aortic valve repair currently is established as an excellent option for patients with BAV. However, with connective tissue disorders being an inherent feature of BAV, outcomes have been less stable long-term than for trileaflet repair, primarily because of late annular redilatation in BAV disease.
Therefore, this study is designed to evaluate the safety and effectiveness of annular stabilization with
Sponsor: Biostable Science & Engineering
Current Primary Outcome:
- Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure. [ Time Frame: 6 months postprocedure ]
- Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months [ Time Frame: 6 months postprocedure ]Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderately Severe (3+), or Severe (4+)
Original Primary Outcome: Survival described as, survival free from all cause death at the 6 month postoperative time point. [ Time Frame: 6 months ]
Current Secondary Outcome:
- 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 following 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 postprocedure ]Freedom from specified clinical cardiovascular events 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
- Actuarial Freedom From Clinical Cardiovascular Events [ Time Frame: 2 years postprocedure ]Freedom from specified clinical cardiovascular events 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: Baseline and 2 years ]Aortic insufficiency assessed by transthoracic echocardiography 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 [ Time Frame: 6 months postprocedure ]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
- NYHA Functional Capacity Classification [ Time Frame: 2 years postprocedure ]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
- Left Ventricular (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.
- Left Ventricular Internal Dimension (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 ]
