Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve

Study Overview
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Brief Summary
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The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.

Detailed Description
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This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be enrolled at up to 35 centers in the US. After replacement of their aortic heart valve with the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the following intervals: discharge, 3 months, 1 year, and annually thereafter for a minimum of five years.

Official Title
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Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent

Conditions
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Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence

Intervention / Treatment
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* Device: EDWARDS INTUITY valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria - Subjects will be required to meet all inclusion criteria: Male or female, age 18 years or older Has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a planned replacement as indicated in the preoperative evaluation Is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery Provide written informed consent Geographically stable and agrees to attend follow-up assessments until all subjects have completed 5 years of follow up Exclusion Criteria: - Exclusion Criteria - Subjects will not be eligible for trial participation if any of the following criteria are present: Pure aortic insufficiency Requires emergency surgery Previous aortic valve replacement Had prior mitral, tricuspid or pulmonic valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ Requires multiple valve replacement/repair Requires a surgical procedure outside of the cardiac area (e.g., vascular endarterectomy, vascular bypass, tumor removal) Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention Active endocarditis/myocarditis or endocarditis/ myocarditis within 3 months prior to the scheduled AVR surgery Myocardial infarction (MI) within thirty (30) days prior to valve replacement surgery Renal insufficiency as determined by creatinine ≥ 2.5 mg/dL at screening or end-stage renal disease requiring chronic dialysis Hyperparathyroidism MRI or CT-scan confirmed cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months (180 days) of the procedure Presence of non-cardiac disease limiting life expectancy to less than 12 months Hypertrophic obstructive cardiomyopathy (HOCM) Left ventricular ejection fraction ≤ 25% Documented history of substance (drug or alcohol) abuse within the last 5 years Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to the procedure Pregnancy, lactation, or planning to become pregnant; Currently incarcerated or unable to give voluntary informed consent Leucopenia (WBC < 3.5x 103/µL), or acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L), or thrombocytopenia (platelet count < 50x 103/µL), or history of bleeding diathesis or coagulopathy History of myxomatous disease/connective tissue disorders (e.g., Marfan's Syndrome) Current or recent participation (within 6 weeks prior to surgery) in an investigational drug or device trial Intra-operative Exclusion Criteria Anatomic variances which contraindicate implant of the trial valve, such as: anomalous coronary arteries annular deformation or extensive calcification of the annulus or aortic root which cannot be removed significant calcium on the anterior mitral leaflet pronounced septal calcification position of coronary ostia relative to Model 8300ACD valve that would result in obstruction of blood flow Available devices are not suitably sized for the subject's annulus

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: EDWARDS INTUITY valve<br>All subjects enrolled into the study are implanted with the EDWARDS INTUITY Valve System. | Device: EDWARDS INTUITY valve<br>* Surgical replacement of the aortic valve with the EDWARDS INTUITY valve.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100] | Events occurring ≥ 31 days and up through 8 years post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success | Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place. | Day of procedure | 
| Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success | Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first. | Day of procedure through discharge or 10 days post index procedure, whichever comes first. | 
| Average Amount of Time Subject Spent on Cardiopulmonary Bypass | Surgical and hospitalization factors - Cardiopulmonary bypass time | Day of procedure | 
| Average Subject Time on Cardiopulmonary Cross Clamp | Surgical and hospitalization factors - Cardiopulmonary cross clamp time | Day of procedure | 
| Average Number of Days Subjects Were in the Intensive Care Unit (ICU) | Length of time surgical subjects were in the intensive care unit (ICU) after their heart valve replacement procedure. | Day of procedure through discharge from the hospital | 
| Subject's New York Heart Association (NYHA) Classification Over Time | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. | Baseline, 3-months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8 Years | 
| Subject's Average Mean Gradient Measurements Over Time | Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up | 
| Subject's Average Peak Gradient Measurements Over Time | Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up | 
| Subject's Effective Orifice Area (EOA) Measurement Over Time | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up | 
| Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up | 
| Subject's Performance Index Measurement Over Time | Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Performance Index is evaluated by echocardiography over time and are dependent on the size and type of the valve. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up | 
| Subject's Cardiac Output Measurement at Over Time | Cardiac output is the amount of blood the heart pumps through the circulatory system in a minute. Cardiac output is evaluated by echocardiography over time. Normal cardiac output in healthy volunteers over 60 years of age was reported between 3.1 and 6.4 liters per minute. In general, a higher value is considered better, and a lower value is considered worse. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up | 
| Subject's Cardiac Index Measurement Over Time | Hemodynamic performance - Cardiac index (CI) evaluated by echocardiography. Cardiac index is an assessment of the cardiac output value based on the patient's size. To obtain the cardiac index, divide the cardiac output by the person's body surface area (BSA). Cardiac Index is a useful marker of how well the heart is functioning as a pump by directly correlating the volume of blood pumped by the heart with an individual's body surface area. Normal cardiac output index in healthy volunteers over 60 years of age was reported between 1.1 and 3.2 L/min/m^2. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up | 
| Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. Higher numbers on the scale show a worsening outcome. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic valve, Heart valve, Tissue valve, Bioprosthesis, Valve disorder, Valve disease, Cardiac surgery, Less invasive cardiac surgery, Aortic valve stenosis, Aortic valve regurgitation, Bovine pericardium