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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-year

Awards & highlights

MRI in TAVR Trial 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.Check my eligibility

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.See study design

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.

MRI in TAVR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 and scheduled for a transfemoral TAVR procedure.

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My heart team has decided I need a valve replacement due to aortic valve stenosis.

MRI in TAVR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effective orifice area (EOA)

Mean gradient

Peak gradient

Secondary outcome measures

Morbidity - disease rate

EOA by echo

Echotomography, Computer

+5 more

MRI in TAVR 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

0 / 2Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research team seeking out participants of a certain age for this clinical trial?

"The eligibility requirements of this trial are such that participants must be 18 to 105 years old. Separately, there exist 24 trials for minors and 161 studies specifically targeting seniors."

Answered by AI

What impact is this medical experiment expected to produce?

"Over the course of a year, this study will seek to measure peak gradient as its primary objective. Secondary outcomes include exercise capacity post TAVR assessed by CMR (METs), left ventricle ejection fraction measured with transthoracic echocardiography (%), and mean gradient evaluated through transthoracic echocardiography (mmHg)."

Answered by AI

Who qualifies as an eligible participant for this research study?

"Qualified candidates for this clinical trial must have aortic valve stenosis and be within the age bracket of 18-105. The research is looking to enrol 90 people in total."

Answered by AI

Are there any vacancies for participants yet in this experiment?

"According to clinicaltrials.gov, this experiment is not currently taking on any new participants. The trial was originally posted January 1st 2023 and last edited November 1st 2022. Although it has closed its doors for recruitment, there are 161 other medical tests actively searching for volunteers as we speak."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MRI in Transcatheter Aortic Valve Replacement Patients

Guilherme Attizzani, MD 2023. "MRI in Transcatheter Aortic Valve Replacement Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05603026.

All > Aortic Stenosis