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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

295 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2017-12-31

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.

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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.

Conditions

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Aortic Valve Stenosis With Insufficiency Aortic Valve Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study Valve

Subjects act as own control

Group Type OTHER

Aortic Valve Replacement with EDWARDS INTUITY Valve System

Intervention Type DEVICE

Aortic Valve bioprosthesis

Interventions

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Aortic Valve Replacement with EDWARDS INTUITY Valve System

Aortic Valve bioprosthesis

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No