Aortic Valve Replacement for Aortic Stenosis
(SMART Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two methods of heart valve replacement in patients with severe narrowing of the heart valve. It aims to see if one method is better at improving blood flow and reducing symptoms without needing major surgery.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is aortic valve replacement with devices like Edwards SAPIEN 3 or Medtronic Evolut PRO generally safe for humans?
Research shows that devices like the Edwards SAPIEN 3 and Medtronic Evolut PRO have been studied for safety, and they are considered safe for high-risk patients needing aortic valve replacement. The FDA has approved the Edwards SAPIEN for high-risk patients, indicating that its benefits outweigh the risks.12345
How does the treatment for aortic stenosis using Edwards SAPIEN 3 or Medtronic Evolut valves differ from other treatments?
The Edwards SAPIEN 3 and Medtronic Evolut valves are used in a procedure called transcatheter aortic valve replacement (TAVR), which is less invasive than traditional open-heart surgery. These valves can be inserted through a small incision, often in the leg, and are designed to expand within the heart to replace the damaged valve, offering a quicker recovery and less risk for patients who may not be suitable for surgery.12567
What data supports the effectiveness of the treatment for aortic valve replacement?
Who Is on the Research Team?
Howard Herrmann, MD
Principal Investigator
University of Pennsylvania, United States
Roxana Mehran, MD
Principal Investigator
Mount Sinai School of Medicine, United States
Didier Tchétché, MD
Principal Investigator
Clinique Pasteur Toulouse, France
Are You a Good Fit for This Trial?
This trial is for adults with severe aortic stenosis and a small aortic annulus who are candidates for valve replacement via TAVR. Participants must be able to attend follow-up visits, have less than 15% risk of mortality from the procedure, suitable anatomy for both Medtronic Evolut and Edwards SAPIEN systems, and access through the femoral artery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TAVR with either a Medtronic SE TAV or an Edwards BE THV
Follow-up
Participants are monitored for safety and effectiveness after treatment
Stress Echocardiography Sub-study
Performance of SE versus BE TAVR evaluated during exercise stress echocardiographic testing
What Are the Treatments Tested in This Trial?
Interventions
- Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
- Medtronic Evolut PRO, Evolut PRO+ or Evolut FX TAV Systems
- Medtronic Evolut PRO or Evolut PRO+ TAV Systems
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medtronic Cardiovascular
Lead Sponsor
Geoff Martha
Medtronic Cardiovascular
Chief Executive Officer since 2020
Finance degree from Penn State University
Dr. Kendra J. Grubb
Medtronic Cardiovascular
Chief Medical Officer
MD from Emory University