Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve

Study Overview
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Brief Summary
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The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.

Detailed Description
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This is a two-phase, non-randomized, prospective, single arm, multi-center clinical investigation. Each subject in Phase 1 and Phase 2 is consented for a period of 5 years. All subjects will be assessed for clinical follow-up at the following intervals: Discharge, 1 month, 3 months, 1 year and annually thereafter until 5 years of follow-up is achieved per subject.

Official Title
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Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve

Conditions
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Aortic Valve Stenosis With Insufficiency, Aortic Valve Stenosis

Intervention / Treatment
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* Device: Aortic Valve Replacement with EDWARDS INTUITY Valve System


Participation Criteria
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Eligibility Criteria
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Criteria: Inclusion Criteria: 18 years or older Aortic stenosis or stenosis-insufficiency of aortic valve requiring a planned replacement as indicated in the preoperative evaluation; Scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, MAZE procedure, septal myectomy, pacemaker/ICD implant and or atrial appendage occlusion/removal. Signed and dated the informed consent form prior to investigation procedures; Geographically stable and agrees to attend Follow up assessments at the hospital of surgical services for a maximum of 5 years. Exclusion Criteria: Pure aortic insufficiency Requires emergency surgery Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention Left ventricular ejection fraction of ≤ 25% Active endocarditis within 3 months prior to the scheduled aortic valve replacement surgery Concomitant valve (mitral, tricuspid, or pulmonic) disease requiring repair with an annuloplasty ring or replacement with prosthesis Prior mitral, tricuspid or pulmonic valve surgery, which included implantation of a bioprosthetic valve, mechanical valve, or annuloplasty ring. Myocardial infarction (MI) within 1 month prior to the scheduled aortic valve replacement surgery Previously implanted with EDWARDS INTUITY Aortic valve; alcohol or drug abuser Disease limiting life expectancy to less than 12 months Pregnant or lactating Currently participating in another drug or device clinical investigation; Documented blood diatheses Requires non-cardiac procedures such as carotid procedures or mediastinal tumor removal Had a stroke or transient ischemic attack (TIA) within 6-months prior to scheduled aortic valve replacement surgery Study site pre-operative echocardiographic assessment shows evidence of an intracardiac mass, thrombus, or vegetation Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days of procedure Documented renal insufficiency as determined by Serum creatinine ≥ 200 µmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis Documented hyperparathyroidism

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 |
| --- | --- |
| Other: Study Valve<br>Subjects act as own control | Device: Aortic Valve Replacement with EDWARDS INTUITY Valve System<br>* Aortic Valve bioprosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Early Adverse Events | Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100. | Events occuring within 30 days of procedure | 
| Percent of Late Adverse Events | Number of late adverse events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). | Events occurring >= 31 days and up through 5 years post-implant | 

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