Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve (TRITON)

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;
• 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%; Congenital bicuspid aortic valve or unicuspid valve;
• 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;
• 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;
• 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