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NCT05459233 · ClinicalTrials.gov registry record · NA

Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR

A NA study of Aortic Valve Stenosis and Aortic Valve Regurgitation, sponsored by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval.

Recruiting
Registry status
NA
Development phase
310
Enrollment target
7
Study locations

NCT05459233 is a NA study of Aortic Valve Stenosis and Aortic Valve Regurgitation that is actively recruiting participants, run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval. The registered enrollment target is 310 participants, below the 1,033-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (70% lower). The trial reports 7 study locations across 7 states.

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The verdict

NCT05459233, a NA study of Aortic Valve Stenosis and Aortic Valve Regurgitation, is actively recruiting participants, sponsored by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval.

RECRUITING
Registry status
NA
Development phase
310 participants
Enrollment target
7
Study locations

Study Summary

Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between echocardiography and catheterization, with an overestimation of the real gradient with echo (vs. cath) in most cases. Thus, the incidence of procedural-device failure may be lower than that reported in the ViV-TAVR literature,

Interventions

  • PROCEDURE Doppler-echocardiography
  • PROCEDURE Invasive hemodynamic measurements

Study Locations (7)

California

  • University of California - San Francisco

Florida

  • South Broward Hospital Disctrict D/B/A Memorial Healthcare System - Hollywood

Michigan

  • William Beaumont Hospital - Royal Oak

Minnesota

  • Mayo Clinic - Rochester

New York

  • St-Joseph's Health INC - Syracuse

Ohio

  • The Christ Hospital Health Network - Cincinnati

Quebec

  • IUCPQ - Québec

Trial Details

FieldValue
Enrollment Target 310 participants
Start Date 2023-01-11
Est. Completion 2029-09-01
Phase NA

What the Registry Record Tells You About NCT05459233

The ClinicalTrials.gov registry entry for NCT05459233 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 310 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,033-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (70% lower). The listed sponsor is Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 2 interventions - of which Doppler-echocardiography is the first listed.

NCT05459233 reports 7 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Michigan.

Frequently Asked Questions

What is clinical trial NCT05459233 about?

NCT05459233 is a clinical study titled "Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR". Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between echocardiography and catheterization, with an overestimation of the real...

What is the current status of trial NCT05459233?

This trial is currently recruiting. It is a NA study. The enrollment target is 310 participants. The study started on 2023-01-11. Estimated completion is 2029-09-01.

What conditions does trial NCT05459233 study?

This clinical trial studies the following conditions: Aortic Valve Stenosis, Aortic Valve Regurgitation, Prosthesis Failure.

What interventions are being tested in trial NCT05459233?

The interventions under investigation include: Doppler-echocardiography (PROCEDURE), Invasive hemodynamic measurements (PROCEDURE).

Who is sponsoring clinical trial NCT05459233?

This trial is sponsored by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05459233 being conducted?

This trial has 7 study locations across California, Florida, Michigan, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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