ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000

Study Overview
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Brief Summary
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This is a prospective, non-randomized, multi-center study designed to evaluate safety and effectiveness of the ATS 3f Enable Aortic Bioprosthesis in a patient population undergoing isolated aortic valve replacement with or without concomitant procedures. The Enable Aortic Valve is an equine pericardial stented bioprosthesis.

Detailed Description
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The ATS 3f Enable Aortic Bioprosthesis is intended for those patients whose prognosis without surgical replacement of the diseased natural valve is unacceptably poor in terms of survival and/or quality of life in the opinion of the attending physicians. For these patients, there are a number of widely accepted prosthetic heart valves in use.

Official Title
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ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000

Conditions
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Heart Valve Diseases

Intervention / Treatment
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* Device: ATS 3f Enable Aortic Bioprosthesis Model 6000


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient requires isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve repair. (The three remaining valves must be of native tissue). The patient is geographically stable and willing to return to the implant site for follow-up visits. The patient has been adequately informed of risks and requirements and consent to his/her participation in the clinical study. If this patient is female and of childbearing potential, patient has a negative pregnancy test within seven (7) days prior to the study procedure. Exclusion Criteria: The patient requires replacement of two or more valves. The patient is < 20 years of age. The patient has a non-cardiac major or progressive disease, which in the Investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 24 months. The patient is an intravenous drug and/or alcohol abuser. The patient presents with active endocarditis or other systemic infection. The patient has had previous valve replacement surgery, including previous implant and then explant of the ATS 3f Enable Aortic Bioprosthesis (Model 6000) or placement of a rigid annuloplasty ring in the mitral position. The patient is participating in concomitant research studies of investigational products. The patient presents with dilatation of the ascending aorta, Marfan Syndrome, Ehlers-Danlos syndrome, cystic medial degeneration, or other condition causing the ascending aorta to be irregular in geometry or physiology as seen via preoperative imaging. The patient has chronic renal failure.

Ages Eligible for Study
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Minimum Age: 21 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: 3f Enable Aortic Bioprosthesis Model 6000<br>Single arm study | Device: ATS 3f Enable Aortic Bioprosthesis Model 6000<br>* Replacement Aortic Heart Valve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thromboembolism/Thrombosis | Valve related thromboembolism and valvular thrombosis. Thrombosis was defined as any thrombus attached to or near the study valve that interfered with valve function in the absence of infection. The results are reported as linearized rate (percentage of participants per patient-year) | Five Years | 
| Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major) | Any episode of internal or external bleeding in subjects receiving anticoagulant and/or antiaggregant therapy. Hemorrhage/Bleeding (No Anticoagulant/Antiaggregant): Any episode of internal or external bleeding in subjects not receiving anticoagulant and/or antiaggregant therapy. The results are reported as linearized rate (percentage of participants per patient-year). | Five Years | 
| Paravalvular Leaks (All and Major) | Paravalvular leak was defined as any evidence of leakage of blood around the prosthesis (between the sewing ring and native annulus). Major Paravalvular leak was defined as any evidence of leakage of blood around the prosthesis, i.e. between the sewing ring and native annulus that requires surgical intervention. The results are reported as linearized rate (percentage of participants per patient-year). | Five Years | 
| Endocarditis | Endocarditis was defined in the protocol as any infection involving the study valve. Any structural/non-structural valvular dysfunction, thrombosis, or embolic event associated with study valve endocarditis was captured as endocarditis only. The results are reported as linearized rate (percentage of participants per patient-year). | Five Years | 
| Hemolysis | Blood data analysis was performed in order to identify whether particular complications and serious adverse events such as hemolysis occurred. Hemolysis in subjects with tissue valves - as evidenced by increased serum lactate dehydrogenase concentrations, decreased serum haptoglobin concentration, erythrocytopenia and reticulocytosis - is usually associated with paravalvular leakage or infection. | Five Years | 
| Structural Valve Deterioration | Structural deterioration was defined as any change in the study valve function which resulted from an intrinsic abnormality that caused stenosis or regurgitation. There were no cases of structural deterioration reported for the study. The results are reported as linearized rate (percentage of participants per patient-year). | Five Years | 
| Non-Structural Dysfunction | Any abnormality resulting in stenosis or regurgitation at the operated valve that is not intrinsic to the valve itself. Non-structural dysfunction refers to non-structural problems that result in dysfunction of an operated valve exclusive of thrombosis and infection diagnosed by reoperation, autopsy, or clinical investigation. The results are reported as linearized rate (percentage of participants per patient-year). | Five Years | 
| Re-operation, Explant, Repair | Reoperation was defined in the protocol as any operation to repair, alter, or replace the study valve. Included is reoperation for repair of paravalvular leak and explant. The results are reported as linearized rate (percentage of participants per patient-year). | Five Years | 
| Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | New York Heart Association (NYHA) classification to asses improvement of the cardiac status, Hemodynamic Performance analysis based on Doppler echocardiographic studies. Class I: Patients with cardiac disease but without limitations of ordinary activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity results in fatigue, palpitations or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest. If any physical activity is undertaken discomfort is increased. | Five Years | 
| Hemodynamic | Mean and peak pressure gradients from discharge through 5 years follow up. The gradient represents the difference in blood pressure across the valve. | Five Years | 
| Hemodynamics - Effective Orifice Area | Effective orifice area (EOA) data. The effective orifice area is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve. | Five Years | 
| Hemodynamics - Effective Orifice Area Index | The effective orifice area index is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve. | Five Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diseased Heart Valve, Replacement, Aortic