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Transcatheter Aortic Valve Replacement

Aortic Valve Replacement for Aortic Stenosis (SMART Trial)

N/A
Waitlist Available
Led By Roxanna Mehran, MD
Research Sponsored by Medtronic Cardiovascular
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has severe aortic stenosis as determined by transthoracic echocardiography (TTE) at rest
Subject's anatomy is suitable for TAVR via transfemoral vessel access
Must not have
Subject has an active COVID-19 infection or relevant history of COVID-19
Subject is less than the legal age of consent, legally incompetent, unable to provide his/her own informed consent, or otherwise vulnerable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 to 5 years annually
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include bleeding, blood vessel complications, irregular heart rhythms, infection risks associated with implants or procedures, stroke, kidney injury, and in rare cases death related to the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with severe aortic stenosis through an echocardiogram.
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My body is fit for a heart valve procedure through my leg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have COVID-19 or have had it before.
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I am under the legal age or unable to give consent due to legal or mental reasons.
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I have had my aortic valve replaced.
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I need an urgent medical procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 to 5 years annually
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 to 5 years annually for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bioprosthetic Valve Dysfunction (BVD)
Mortality, disabling stroke or heart failure rehospitalization
Other study objectives
BVD
Echocardiographic measurements
Incidence of an early safety composite
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

Medtronic CardiovascularLead Sponsor
75 Previous Clinical Trials
35,457 Total Patients Enrolled
Roxanna Mehran, MDPrincipal InvestigatorMount Sinai School of Medicine, United States
Didier Tchétché, MDPrincipal InvestigatorClinique Pasteur Toulouse, France
1 Previous Clinical Trials
150 Total Patients Enrolled

Media Library

Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems (Transcatheter Aortic Valve Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT04722250 — N/A
Aortic Stenosis Research Study Groups: Edwards Balloon-Expandable THV, Medtronic Self-Expanding TAV
Aortic Stenosis Clinical Trial 2023: Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems Highlights & Side Effects. Trial Name: NCT04722250 — N/A
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems (Transcatheter Aortic Valve Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04722250 — N/A
~156 spots leftby Nov 2025
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