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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04827238
Other study ID # H21-00824
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 30, 2021
Est. completion date December 31, 2023

Study information

Verified date June 2023
Source University of British Columbia
Contact Denise Spacek
Phone 6048381081
Email dspacek@cci-cic.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Since the introduction of Doppler echocardiography, non-invasive estimation of aortic valve gradients through modification and simplification of the Bernoulli equation and derivation of the AVA, via the continuity equation, have become the primary method to assess the severity of AS. The utility of echocardiography to successfully determine aortic valve gradients and AVA has been established in the presence of AS, and such observations have been extrapolated to prosthetic valves. However, several reports following SAVR and TAVR for both native and valve-in-valve have demonstrated significant discordance between echocardiography-derived and direct invasive measurements of aortic valve mean gradients. The indexed AVA (iAVA) is derived from the stroke volume indexed to the BSA. The stroke volume index (SVI) divided by the Doppler velocity time integral of the continuous wave aortic valve spectral profile, is used to determine the presence of severe PPM. As such, a low iAVA may occur due to a low flow state defined by a reduced SVI (<35 ml/m2) or a reduced stroke flow rate (< 200 ml/second) and calculated by dividing the SV by the ejection time spuriously increasing the incidence of severe PPM. A low indexed effective orifice area due to a low SVI, in the absence of intrinsic PPM, has been referred to as "pseudo-severe PPM", but the impact of flow state on PPM has not been described. Nonetheless, echocardiographic thresholds for the evaluation of prosthetic valve performance after TAVR have been widely adopted: mean-gradient > 20mmHg, severe PPM as defined by an iAVA < 0.65 cm2/m2, and AR, including paravalvular and transvalvular AR of moderate or greater severity. These criteria are suggested to indicate procedural success and predict long-term clinical outcomes (12). Practically many centers utilize an echocardiography-derived mean gradient for the follow-up of transcatheter heart valves. While the association of at least moderate paravalvular AR with mortality has been consistently demonstrated, there remains uncertainty regarding the clinical impact of severe PPM as determined by index echocardiography. Furthermore, the magnitude of discordance between echocardiography-derived and invasive aortic valve mean-gradients post TAVR is unknown and it remains unclear how to reconcile measurement discordances in clinical practice. These potential differences may have an important impact on patient management post TAVR. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2023
Est. primary completion date November 15, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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). Exclusion Criteria: - CT demonstrating leaflet thrombosis or hypoattenuated leaflet thickening (HALT)

Study Design


Intervention

Diagnostic Test:
Standardized Invasive Hemodynamics
The SIH technique is a standardized, reproducible and efficient way of obtaining hemodynamic measurements.

Locations

Country Name City State
Canada McMaster University Hamilton Ontario
Canada St. Paul's Hospital Vancouver British Columbia
Canada Vancouver General Hospital Vancouver British Columbia
United States Tenet Health Boca Raton Florida
United States Massachusetts General Hospital Boston Massachusetts
United States Baylor Scott & White Dallas Texas
United States eCommunity Indianapolis Indiana
United States Community Hospital Munster Indiana
United States William Beaumont Hospital Southfield Michigan
United States PIMA Heart Centre Tucson Arizona

Sponsors (2)

Lead Sponsor Collaborator
University of British Columbia Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Transaortic valve gradients Transaortic valve gradients measured by echocardiography and direct invasive methods 30 days
Primary Transaortic mean gradient reclassification Proportion of patients reclassified to a transaortic mean gradient < 20mmHg using direct invasive methods 30 days
Primary 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
Primary Patient-Prosthesis Mismatch (PPM) reclassification Proportion of patients with echocardiographic severe PPM reclassified as non-severe PPM using direct invasive methods 30 days
Secondary Total procedure time Total procedure time (mins) to complete standardized invasive hemodynamics 30 days
Secondary Risks of procedural complications Evaluate risks of procedural complications associated with direct-invasive hemodynamics 30 days
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