Condition: Aortic stenosis
Key Inclusion Criteria
- Severe, calcific aortic stenosis
- New York Heart Association functional class ≥II
- At intermediate risk for open surgical therapy
Key Exclusion Criteria
- Native aortic annulus size unsuitable for sizes 23, 26 or 29 mm CENTERA THV
- Aortic valve is unicuspid, bicuspid or non-calcified
- Pre-existing mechanical or bioprosthetic valve in any position
Full Study Name
A Prospective, Single-Arm, Controlled, Multicenter Study to Establish the Safety and Effectiveness of the CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement (IRB no. 53927)
The purpose of this study is to evaluate the safety and effectiveness of an investigational device called Edwards CENTERA Transcatheter Heart Valve System (THV)- Model 9551 in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement. Aortic stenosis is a critical narrowing of the aortic valve. Participants in this study will have a procedure called transcatheter aortic valve replacement (TAVR) using the CENTERA THV (rather than one of the valves that is usually used for TAVR).
The Edwards CENTERA THV device is an artificial heart valve. It is made to replace a diseased aortic heart valve. Each valve consists of a short metal tube (“stent”) that holds the valve in its intended position and has valve leaflets to direct the flow of blood through the heart the way a normal valve would. The artificial valve is delivered into the heart through a small flexible tube (catheter).