NCT04827238

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

August 30, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

3.8 years

First QC Date

March 29, 2021

Last Update Submit

July 22, 2025

Conditions

Aortic StenosisAortic Valve Stenosis

Outcome Measures

Primary Outcomes (4)

  • Transaortic valve gradients

    Transaortic valve gradients measured by echocardiography and direct invasive methods

    30 days

  • Transaortic mean gradient reclassification

    Proportion of patients reclassified to a transaortic mean gradient \< 20mmHg using direct invasive methods

    30 days

  • VARC-3 hemodynamic valve deterioration reclassification

    Proportion of patients reclassified to ≤ moderate VARC-3 hemodynamic valve deterioration using direct invasive methods, including mean gradient and valve area, compared to echocardiography

    30 days

  • Patient-Prosthesis Mismatch (PPM) reclassification

    Proportion of patients with echocardiographic severe PPM reclassified as non-severe PPM using direct invasive methods

    30 days

Secondary Outcomes (2)

  • Total procedure time

    30 days

  • Risks of procedural complications

    30 days

Study Arms (1)

Patients with Elevated Gradients Post Transcatheter Aortic Valve Replacement

Patients who have an echocardiographic transaortic mean gradient ≥ 20mmHg OR VARC-3 criteria for ≥ moderate hemodynamic valve deterioration post TAVR on any TTE \> 1 month post-TAVR

Diagnostic Test: Standardized Invasive Hemodynamics

Interventions

Standardized Invasive HemodynamicsDIAGNOSTIC_TEST

The SIH technique is a standardized, reproducible and efficient way of obtaining hemodynamic measurements.

Patients with Elevated Gradients Post Transcatheter Aortic Valve Replacement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients \> 1 month post-transcatheter aortic valve replacement

You may qualify if:

  • Echocardiographic transaortic mean gradient ≥ 20mmHg OR VARC-3 criteria for ≥ moderate hemodynamic valve deterioration post TAVR on any TTE \> 1 month post-TAVR
  • Consensus by the Heart Team that the patient is suitable for Standardized Invasive Hemodynamics (SIH).

You may not qualify if:

  • CT demonstrating leaflet thrombosis or hypoattenuated leaflet thickening (HALT)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

PIMA Heart Centre

Tucson, Arizona, 85712, United States

Location

Tenet Health

Boca Raton, Florida, 33484, United States

Location

eCommunity

Indianapolis, Indiana, 46256, United States

Location

Community Hospital

Munster, Indiana, 46321, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

William Beaumont Hospital

Southfield, Michigan, 48076, United States

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • David Wood, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 1, 2021

Study Start

August 30, 2021

Primary Completion

June 20, 2025

Study Completion

June 20, 2025

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(6)CA(3)