RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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,

Official Title

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

Quick Facts

Study Start:2023-01-11
Study Completion:2029-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05459233

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Surgical stented bioprosthetic valve (label size ≤25 mm)
  3. * TAVR with the SAPIEN 3 Ultra valve
  1. * Stentless or sutureless surgical valves
  2. * Trifecta bioprosthesis
  3. * Hancock II bioprosthesis
  4. * 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).
  5. * Impossibility to obtain written informed consent

Contacts and Locations

Study Contact

Josep Rodés-Cabau, MD
CONTACT
418-656-8711
josep.rodes@criucpq.ulaval.ca
Emilie Pelletier Beaumont, MSc
CONTACT
418-656-8711
emilie.pelletier-beaumont@criucpq.ulaval.ca

Principal Investigator

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

Study Locations (Sites)

University of California
San Francisco, California, 94143
United States
South Broward Hospital Disctrict D/B/A Memorial Healthcare System
Hollywood, Florida, 33021
United States
William Beaumont Hospital
Royal Oak, Michigan, 48073
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
St-Joseph's Health INC
Syracuse, New York, 13203
United States
The Christ Hospital Health Network
Cincinnati, Ohio, 45219
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-11
Study Completion Date2029-09-01

Study Record Updates

Study Start Date2023-01-11
Study Completion Date2029-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Aortic Valve Stenosis
  • Aortic Valve Regurgitation
  • Prosthesis Failure