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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 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.

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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.

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

FieldValue
Enrollment Target 90 participants
Start Date 2023-11-21
Est. Completion 2026-12-30
Phase NA

What the Registry Record Tells You About NCT05603026

The ClinicalTrials.gov registry entry for NCT05603026 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,040-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (91% lower). The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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