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

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04827238
• Other study ID #: H21-00824
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

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