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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: Recruiting NA study of Aortic Valve Stenosis and Aortic Valve Regurgitation, sponsored by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval.
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. According to ClinicalTrials.gov, the official US trial registry.
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,
Primary Outcome
Change in quality of life as evaluated by the Kansas City Cardiomyopathy Questionnaire (KCCQ). All score are represented on a 0-to-100-point scale (lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life).The KCCQ is a 7 domains questionnaire; symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2023-01-11 |
| Est. Completion | 2029-09-01 |
| Phase | NA |
Sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval1 total trials
What NCT05459233 shows while recruiting
NCT05459233 is an interventional study that assigns participants to a tested intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, below the 1,033-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (70% lower).
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 lists 7 locations in 7 states (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.
Learn More About Clinical Trials
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Where NCT05459233's enrollment target sits among peer trials
310 12th of 30 higher than 19 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.
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