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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 to 5 years annually
Awards & highlights
SMART Trial Summary
This trial is comparing two types of aortic valve replacement surgery in people with a small aortic annulus and severe native aortic stenosis. Additionally, there is a sub-study that will be conducted at select sites evaluating the performance of the two types of surgery after exercise stress echocardiographic testing.
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.Check my eligibility
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.See study design
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.
SMART Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with severe aortic stenosis through an echocardiogram.
Select...
My body is fit for a heart valve procedure through my leg.
SMART Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 to 5 years annually
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 to 5 years annually
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bioprosthetic Valve Dysfunction (BVD)
Mortality, disabling stroke or heart failure rehospitalization
Secondary outcome measures
Aortic valve mean gradient as a continuous variable
Effective Orifice Area (EOA) as a continuous variable
Percentage of participants with BVD in female subjects
+2 moreOther outcome measures
6-minute walk test (6MWT) change from baseline
Aortic valve re-intervention rate
BVD
+10 moreSMART 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.
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Who is running the clinical trial?
Medtronic CardiovascularLead Sponsor
75 Previous Clinical Trials
35,616 Total Patients Enrolled
Roxanna Mehran, MDPrincipal InvestigatorMount Sinai School of Medicine, United States
Roxana Mehran, MDPrincipal InvestigatorMount Sinai School of Medicine, United States
15 Previous Clinical Trials
41,950 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with severe aortic stenosis through an echocardiogram.My body is fit for a heart valve procedure through my leg.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.Your doctors think the risk of serious complications during surgery is less than 15%.Your body shape is suitable for either of the two types of heart valves.My doctors agree I need a valve replacement due to my symptoms.You cannot be treated with the Evolut PRO/PRO+/FX or Edwards SAPIEN 3/3 Ultra TAV according to the instructions for using these devices.I have had my aortic valve replaced.Your aortic valve is too small based on a specific type of imaging test.Doctors think you might live for less than 2 years.I need an urgent medical procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Edwards Balloon-Expandable THV
- Group 2: Medtronic Self-Expanding TAV
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Where are the current locales offering this trial?
"Currently, 67 sites are taking on patients for this study. Some of the more notable locations include Toronto, Morgantown and New york; however there are a myriad of other places you can be evaluated at as well. Selecting the closest site is recommended in order to reduce any travel burden if you do choose to participate."
Answered by AI
Are there any open enrollment slots left for this research project?
"As indicated by clinicaltrials.gov, the recruitment phase for this trial has concluded; it was initially posted on April 2nd 2021 and last updated November 4th 2022. Despite its closure, 309 other studies are actively looking to enrol patients."
Answered by AI
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