Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05459233

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

Led by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Updated on 2026-03-24

310

Participants Needed

7

Research Sites

346 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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,

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and/or regurgitation approved for a valve-in-valve procedure by the Heart Team
  • Surgical stented bioprosthetic valve with a labeled size of 25 mm or less
  • Undergoing TAVR with the SAPIEN 3 Ultra valve
Not Eligible

You will not qualify if you...

  • Stentless or sutureless surgical valves
  • Trifecta bioprosthesis
  • Hancock II bioprosthesis
  • High risk of coronary obstruction defined by a virtual transcatheter valve to coronary distance less than 4 mm on CT or by Heart Team assessment
  • Inability to provide written informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

University of California

San Francisco, California, United States, 94143

Not Yet Recruiting

2

South Broward Hospital Disctrict D/B/A Memorial Healthcare System

Hollywood, Florida, United States, 33021

Actively Recruiting

3

William Beaumont Hospital

Royal Oak, Michigan, United States, 48073

Actively Recruiting

4

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

5

St-Joseph's Health INC

Syracuse, New York, United States, 13203

Not Yet Recruiting

6

The Christ Hospital Health Network

Cincinnati, Ohio, United States, 45219

Actively Recruiting

7

IUCPQ

Québec, Quebec, Canada, G1V 4G5

Actively Recruiting

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Research Team

J

Josep Rodés-Cabau, MD

CONTACT

E

Emilie Pelletier Beaumont, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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