COMPLETED

Standardized Invasive Hemodynamics for Elevated Gradients Post TAVR (DISCORDANCE 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

The DISCORDANCE TAVR study will determine the discordance between echocardiography-derived and invasive transaortic gradients, as determined by a consistent and reproducible technique (Standardized Invasive Hemodynamics) post-TAVR.

Official Title

Standardized Invasive Hemodynamics for Monitoring Acute and Long Term Valve Performance in Patients With Elevated Gradients Post Transcatheter Aortic Valve Replacement

Quick Facts

Study Start:2021-08-30
Study Completion:2025-06-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04827238

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:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Echocardiographic transaortic mean gradient ≥ 20mmHg OR VARC-3 criteria for ≥ moderate hemodynamic valve deterioration post TAVR on any TTE \> 1 month post-TAVR
  2. * Consensus by the Heart Team that the patient is suitable for Standardized Invasive Hemodynamics (SIH).
  1. * CT demonstrating leaflet thrombosis or hypoattenuated leaflet thickening (HALT)

Contacts and Locations

Principal Investigator

David Wood, MD
PRINCIPAL_INVESTIGATOR
University of British Columbia

Study Locations (Sites)

PIMA Heart Centre
Tucson, Arizona, 85712
United States
Tenet Health
Boca Raton, Florida, 33484
United States
eCommunity
Indianapolis, Indiana, 46256
United States
Community Hospital
Munster, Indiana, 46321
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
William Beaumont Hospital
Southfield, Michigan, 48076
United States

Collaborators and Investigators

Sponsor: University of British Columbia

  • David Wood, MD, PRINCIPAL_INVESTIGATOR, University of British Columbia

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 Date2021-08-30
Study Completion Date2025-06-20

Study Record Updates

Study Start Date2021-08-30
Study Completion Date2025-06-20

Terms related to this study

Additional Relevant MeSH Terms

  • Aortic Stenosis
  • Aortic Valve Stenosis