Aortic Valve Replacement for Aortic Stenosis

(SMART Trial)

Recruiting at 93 trial locations

Overseen By SMART Trial Clinical Study Team

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medtronic Cardiovascular

No Placebo Group

Trial Summary

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.

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

Eligibility Criteria

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

I have been diagnosed with severe aortic stenosis through an echocardiogram.

My body is fit for a heart valve procedure through my leg.

Your doctors think the risk of serious complications during surgery is less than 15%.

Exclusion Criteria

I currently have COVID-19 or have had it before.

I have severe heart artery disease or issues with my heart's main artery.

I am under the legal age or unable to give consent due to legal or mental reasons.

Treatment Details

Interventions

• Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems (Transcatheter Aortic Valve Replacement)
• Medtronic Evolut PRO, Evolut PRO+ or Evolut FX TAV Systems (Transcatheter Aortic Valve Replacement)
• Medtronic Evolut PRO or Evolut PRO+ TAV Systems (Transcatheter Aortic Valve Replacement)

Trial Overview The trial compares two types of heart valve systems: self-expanding (Medtronic Evolut PRO/PRO+/FX) versus balloon-expandable (Edwards SAPIEN 3/3 Ultra) in patients needing transcatheter aortic valve replacement. It includes an exercise stress echocardiography sub-study at some locations.

Participant Groups

Group I: Medtronic Self-Expanding TAV Experimental Treatment 1 Intervention

Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.

Group II: Edwards Balloon-Expandable THV Experimental Treatment 1 Intervention

Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.

Who Is Running the Clinical Trial?

Medtronic Cardiovascular

Lead Sponsor

Trials

78

Recruited

37,300+

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