1103 Participants Needed

Aortic Valve Replacement for Aortic Stenosis

(SMART Trial)

Recruiting at 93 trial locations
ST
Overseen BySMART Trial Clinical Study Team
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medtronic Cardiovascular
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research shows that the Edwards SAPIEN 3 and Medtronic Evolut valves are effective for transcatheter aortic valve replacement (TAVR), with high success rates and improved safety in patients. Studies comparing these devices indicate they both perform well, with device success rates of over 90%.12358

Who Is on the Research Team?

HH

Howard Herrmann, MD

Principal Investigator

University of Pennsylvania, United States

RM

Roxana Mehran, MD

Principal Investigator

Mount Sinai School of Medicine, United States

DT

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

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%.
See 4 more

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.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TAVR with either a Medtronic SE TAV or an Edwards BE THV

Immediate post-procedure to discharge
Pre-procedure, post-procedure, and at discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
30 days, 12 months, and annually until 5 years

Stress Echocardiography Sub-study

Performance of SE versus BE TAVR evaluated during exercise stress echocardiographic testing

Conducted at 12-month visit
1 visit (in-person) at select sites

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
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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Medtronic Self-Expanding TAVExperimental Treatment1 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 THVExperimental Treatment1 Intervention
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.

Find a Clinic Near You

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

Published Research Related to This Trial

The review highlights the clinical outcomes and design features of two leading transcatheter aortic valve replacement (TAVR) valves, the Edwards SAPIEN S3 and Medtronic Evolut PRO+, comparing their effectiveness in treating aortic stenosis based on multiple trials.
While TAVR technology has significantly improved the management of aortic stenosis, ongoing advancements are needed to enhance safety during surgery and to develop more durable valve options.
Current and future transcatheter aortic valve replacement valves.Eikelboom, R., Moran, RM., Yan, W., et al.[2023]
In a study of 563 patients undergoing transcatheter aortic valve replacement (TAVR) with either balloon-expandable (BE) or self-expandable (SE) valves, the SE valves were associated with a higher risk of ischemic stroke at 30 days (6.0% vs 1.4%), although other outcomes like mortality and readmission rates were similar between the two types.
Midterm outcomes for both BE and SE valves were comparable, suggesting that while SE valves may pose a short-term stroke risk, overall survival and readmission rates do not significantly differ, indicating that patient selection based on clinical factors is important for optimal valve choice.
Outcomes of Current-Generation Transfemoral Balloon-Expandable Versus Self-Expandable Transcatheter Aortic Valve Replacement.Habertheuer, A., Gleason, TG., Kilic, A., et al.[2021]
In a review of 6 studies involving 1,664 patients, both the Edwards SAPIEN S3 (ES3) and Medtronic's Evolut R transcatheter heart valves showed similar safety profiles and procedural success rates, with no significant differences in 30-day mortality, stroke, or major complications.
However, the ES3 group had a higher risk of acute kidney injury, while the Evolut R group had a higher rate of new permanent pacemaker implantation, indicating different safety considerations for each device.
Comparison of third generation balloon-expandable Edwards Sapien 3 versus self-expandable Evolut R in transcatheter aortic valve implantation: a meta-analysis.Li, YM., Tsauo, JY., Liao, YB., et al.[2021]

Citations

Current and future transcatheter aortic valve replacement valves. [2023]
Outcomes of Current-Generation Transfemoral Balloon-Expandable Versus Self-Expandable Transcatheter Aortic Valve Replacement. [2021]
Comparison of third generation balloon-expandable Edwards Sapien 3 versus self-expandable Evolut R in transcatheter aortic valve implantation: a meta-analysis. [2021]
Multicenter comparison of latest-generation balloon-expandable versus self-expanding transcatheter heart valves: Ultra versus Evolut. [2022]
Comparison of the Edwards SAPIEN S3 Versus Medtronic Evolut-R Devices for Transcatheter Aortic Valve Implantation. [2022]
Overview of the 2012 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting on the Edwards SAPIEN transcatheter heart valve for high-risk aortic stenosis patients. [2013]
Meta-analysis of short- and long-term clinical outcomes of the self-expanding Evolut R/pro valve versus the balloon-expandable Sapien 3 valve for transcatheter aortic valve implantation. [2022]
Transcatheter Aortic Valve Replacement With Balloon-Expandable Valves: Comparison of SAPIEN 3 Ultra Versus SAPIEN 3. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security