Standardized Invasive Hemodynamics for Elevated Gradients Post TAVR (DISCORDANCE TAVR)

NCT ID: NCT04827238

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-30
• Study Completion Date: 2025-06-20

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.

Detailed 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.

Conditions

Aortic Stenosis; Aortic Valve Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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

Standardized Invasive Hemodynamics

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Standardized Invasive Hemodynamics

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

David Wood

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Wood, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

PIMA Heart Centre

Tucson, Arizona, United States

Tenet Health

Boca Raton, Florida, United States

eCommunity

Indianapolis, Indiana, United States

Community Hospital

Munster, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

William Beaumont Hospital

Southfield, Michigan, United States

Vancouver General Hospital

Vancouver, British Columbia, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

McMaster University

Hamilton, Ontario, Canada

Countries

United States; Canada

Other Identifiers

H21-00824

Identifier Type: -

Identifier Source: org_study_id