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Prosthetic Valve

MRI-Guided Valve Replacement for Aortic Valve Stenosis (MRI in TAVR Trial)

N/A
Recruiting
Led By Sadeer Al-Kindi, MD
Research Sponsored by Guilherme Attizzani, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planned transfemoral TAVR; 18 years of age or older
Aortic valve stenosis with clinical indication for valve replacement decided by a dedicated heart team
Must not have
Significant non-treated coronary artery disease
History of surgical aortic valve replacement or patients who undergo a valve-in-valve TAVR procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare 2 types of mitral valve replacement, SEV & BEV, to see which is better in terms of blood flow & exercise capacity, using CMR for a more precise assessment.

Who is the study for?
This trial is for adults with aortic valve stenosis who need a valve replacement and can undergo the procedure through their leg artery. They must be able to consent, have no severe heart issues like reduced heart function or untreated coronary disease, no history of valve replacements, and no implants that are unsafe for MRI.
What is being tested?
The study tests if self-expanding valves (Medtronic Evolut FX) provide better blood flow and exercise capacity compared to balloon-expanding valves (Edwards Sapien 3 Ultra), using stress cardiac MRI to measure differences in heart performance.
What are the potential side effects?
Potential side effects may include discomfort from the MRI process, risks associated with transcatheter aortic valve replacement such as bleeding or vascular complications, and possible allergic reactions to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 and scheduled for a transfemoral TAVR procedure.
Select...
My heart team has decided I need a valve replacement due to aortic valve stenosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have untreated heart artery problems.
Select...
I have had a surgical aortic valve replacement or a valve-in-valve TAVR procedure.
Select...
My heart's pumping ability is reduced.
Select...
My heart rhythm is stable and does not interfere with heart imaging tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effective orifice area (EOA)
Mean gradient
Peak gradient
Secondary study objectives
Morbidity - disease rate
EOA by echo
Echotomography, Computer
+5 more

Awards & Highlights

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

Trial Design

2Treatment groups
Active Control
Group I: TAVR using the self-expanding valve Evolut FXActive Control1 Intervention
Transcatheter aortic valve replacement (TAVR) using the bioprosthesis Medtronic Evolut FX supra-annular self-expanding valve
Group II: TAVR using the balloon-expandable valve Sapien 3 UltraActive Control1 Intervention
Transcatheter aortic valve replacement (TAVR) using the bioprosthesis Edwards Sapien 3 Ultra valve

Find a Location

Who is running the clinical trial?

Guilherme Attizzani, MDLead Sponsor
Sadeer Al-Kindi, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
2 Previous Clinical Trials
7,013 Total Patients Enrolled

Media Library

Balloon-expanding valve (Edwards Sapien 3 Ultra) (Prosthetic Valve) Clinical Trial Eligibility Overview. Trial Name: NCT05603026 — N/A
Aortic Valve Stenosis Research Study Groups: TAVR using the self-expanding valve Evolut FX, TAVR using the balloon-expandable valve Sapien 3 Ultra
Aortic Valve Stenosis Clinical Trial 2023: Balloon-expanding valve (Edwards Sapien 3 Ultra) Highlights & Side Effects. Trial Name: NCT05603026 — N/A
Balloon-expanding valve (Edwards Sapien 3 Ultra) (Prosthetic Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05603026 — N/A
~7 spots leftby Dec 2024
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