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MRI in Transcatheter Aortic Valve Replacement Patients

This study is looking at two types of replacement heart valves for people with aortic valve stenosis (a narrowing of the heart's aortic valve). Researchers want to see if the self-expanding Medtronic Evolut FX valve offers better heart function and exercise ability compared to the balloon-expanding Edwards Sapien 3 Ultra RESILIA valve. They will use MRI scans to measure how well the valves are working and how they affect your heart. The study aims to enroll 90 participants aged 18 to 105 who need a transcatheter aortic valve replacement (TAVR) and can give informed consent. The main goals are to measure how well the valves open (effective orifice area) and the pressure across them (mean and peak gradient) at different times after the procedure.

Study design
This interventional study plans to enroll 90 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least one year after the valve replacement, with measurements taken at baseline, 30 days, and one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05603026

MRI in Transcatheter Aortic Valve Replacement Patients

Recruiting
NAAges 18+InterventionalTreatment
University Hospitals Cleveland Medical Center
~90 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:Self-expanding valve (Medtronic Evolut FX)Balloon-expanding valve (Edwards Sapien 3 Ultra RESILIA)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effective orifice area (EOA)
Measured over Baseline, 30-days and 1-year
+2 more outcomes measured

Conditions

Aortic Valve Stenosis

Explore related trials

Aortic Valve Stenosis

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Guilherme Attizzani, MD · PRINCIPAL_INVESTIGATOR · UH, Cleveland Medical Center
  • Sadeer Al-Kindi, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center

Who to contact

Luis Dallan, MD
[email protected]
216-844-1000
Email the study team

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Eligibility criteria

Inclusion

Aortic valve stenosis with clinical indication for valve replacement decided by a dedicated heart team;
Planned transfemoral TAVR; 18 years of age or older;
Able to give informed consent.

Exclusion

Patients with permanent pacemakers or implantable defibrillators;
Patients with non-MRI safe implants;
Severe claustrophobia;
Inability or contraindication to perform exercise bike stress test;
Arrhythmia which would prevent adequate cardiac gating, including atrial fibrillation;
Reduced left ventricular systolic function (\<40%);
History of surgical aortic valve replacement or patients who undergo a valve-in-valve TAVR procedures;
Significant non-treated coronary artery disease.

What this trial measures

  • Effective orifice area (EOA)Baseline, 30-days and 1-year

    Change in effective orifice area (EOA) assessed by CMR between baseline and 1-year follow up (cm2)

  • Mean gradient1-year

    Mean AV gradient assessed by CMR (mmHg)

  • Peak gradient1-year

    Mean AV gradient assessed by CMR (mmHg)