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NCT05603026 · ClinicalTrials.gov registry record · NA
MRI in Transcatheter Aortic Valve Replacement Patients
A NA study of Aortic Valve Stenosis, sponsored by University Hospitals Cleveland Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT05603026: Recruiting NA study of Aortic Valve Stenosis, sponsored by University Hospitals Cleveland Medical Center.
NCT05603026 is a NA study of Aortic Valve Stenosis that is actively recruiting participants, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 90 participants, below the 1,040-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05603026, a NA study of Aortic Valve Stenosis, is actively recruiting participants, sponsored by University Hospitals Cleveland Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
The hypothesis is that SEV result in superior valvular hemodynamics (more pronounced during exercise) and exercise capacity relative to BEV. Furthermore, the hypothesis is that stress CMR will be able to demonstrate differences in these hemodynamic parameters. CMR will also provide refined assessment of paravalvular leak and its impact on ventricular function and on clinical outcomes.
Primary Outcome
Change in effective orifice area (EOA) assessed by CMR between baseline and 1-year follow up (cm2)
Conditions Studied
Interventions
- DEVICE Self-expanding valve (Medtronic Evolut FX)
- DEVICE Balloon-expanding valve (Edwards Sapien 3 Ultra RESILIA)
Study Locations (1)
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2023-11-21 |
| Est. Completion | 2026-12-30 |
| Phase | NA |
What NCT05603026 shows while recruiting
NCT05603026 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 1,040-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 2 interventions - of which Self-expanding valve (Medtronic Evolut FX) is the first listed.
NCT05603026 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05603026 about?
NCT05603026 is a clinical study titled "MRI in Transcatheter Aortic Valve Replacement Patients". The hypothesis is that SEV result in superior valvular hemodynamics (more pronounced during exercise) and exercise capacity relative to BEV. Furthermore, the hypothesis is that stress CMR will be able to demonstrate differences in these hemodynamic parameters. CMR will also provide refined assessmen...
What is the current status of trial NCT05603026?
This trial is currently recruiting. It is a NA study. The enrollment target is 90 participants. The study started on 2023-11-21. Estimated completion is 2026-12-30.
What conditions does trial NCT05603026 study?
This clinical trial studies the following conditions: Aortic Valve Stenosis.
What interventions are being tested in trial NCT05603026?
The interventions under investigation include: Self-expanding valve (Medtronic Evolut FX) (DEVICE), Balloon-expanding valve (Edwards Sapien 3 Ultra RESILIA) (DEVICE).
Who is sponsoring clinical trial NCT05603026?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05603026 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05603026's enrollment target sits among peer trials
90 21st of 30 higher than 10 of 30 other Aortic Valve Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Valve Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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