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

Description

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

Aortic Valve Stenosis, Aortic Valve Regurgitation, Prosthesis Failure

Study Overview

Study Details

Study overview

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,

Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial

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

Condition
Aortic Valve Stenosis
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, California, United States, 94143

Hollywood

South Broward Hospital Disctrict D/B/A Memorial Healthcare System, Hollywood, Florida, United States, 33021

Royal Oak

William Beaumont Hospital, Royal Oak, Michigan, United States, 48073

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Syracuse

St-Joseph's Health INC, Syracuse, New York, United States, 13203

Cincinnati

The Christ Hospital Health Network, Cincinnati, Ohio, United States, 45219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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 (label size ≤25 mm)
  • * TAVR with the SAPIEN 3 Ultra valve
  • * Stentless or sutureless surgical valves
  • * Trifecta bioprosthesis
  • * Hancock II bioprosthesis
  • * High-risk of coronary obstruction (defined either as a virtual transcatheter valve - coronary distance as evaluated by CT \<4 mm or based on the criterion of the heart team responsible for the procedure).
  • * Impossibility to obtain written informed consent

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval,

Josep Rodés-Cabau, MD, PRINCIPAL_INVESTIGATOR, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Study Record Dates

2029-09-01