Aortic Valve replacement for low risk surgery patients (EVOLUTR valve)
Trial ID:
IRB-16-6797
Paul S. Teirstein, M.D., FACC
This study is evaluating the safety and effectiveness of transcatheter aortic valve replacement (TAVR) compared to conventional surgical aortic valve replacement (SAVR) in patients with severe Aortic Stenosis who are considered at low risk for conventional surgical treatment. All screening requirements must be met prior to enrollment. Patients will have clinic follow-up visits for safety evaluations after the procedure and at 30 days, 6 months, 18 months and then annually for up to 5 years.
Inclusion Criteria
Have severe aortic stenosis
Be considered low risk for traditional Aortic valve surgery
Meet all other eligibility criteria
Exclusion Criteria
Have refused the possibility of surgery for valve replacement as a treatment option
Have a previous prosthetic heart valve or other valve implanted in any position
Several other exclusions exist. Please contact site for more information.
Additional Info
Patients will be randomized to receive either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR).