Study ID: PARTNER 3
PARTNER 3: A study to establish the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients who have severe, calcific, aortic stenosis requiring aortic valve replacement and are at low risk for requiring a surgical valve replacement.
This trial is the first ever U.S. clinical trial involving the transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis who are at low risk for traditional surgery. The goal of the study is to show that TAVR results are comparable to surgical aortic valve replacements (SAVR) in low-risk surgical patients. Study participants will be randomly assigned to receive a TAVR vs. SAVR.
Determining your eligibility for the PARTNER 3 trial may include screening and testing, such as:
Patients who enroll in this clinical trial are followed for 10 years.
PARTNER 3 is a prospective, randomized, controlled, multi-center study to establish the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in low-risk patients who have severe, calcific, aortic stenosis requiring aortic valve replacement
The purpose of this trial is to establish the safety and efficacy of the Edwards SAPIEN 3 THV device in patients with severe, calcific, symptomatic aortic stenosis who are at low operative risk for SAVR.
This is a prospective, randomized, controlled, multi-center study. Qualifying study patients will be randomized 1:1 to receive either a transcatheter heart valve replacement, using Edwards SAPIEN 3 heart valve, or a surgical aortic valve replacement using a commercially available bioprosthetic valve. Patients are followed for 10 years.
- Must have symptoms of aortic valve stenosis
- Must be considered by the heart team as low risk for surgery
- Must agree to comply with the agreement to attend all follow-up appointments for a period of 10 years after the procedure
Additional criteria may apply.