Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
The purpose of this clinical investigation is to confirm that the safety and performance of
 the EDWARDS INTUITY Valve System.
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.
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