Status:
COMPLETED
Standardized Invasive Hemodynamics for Elevated Gradients Post TAVR (DISCORDANCE TAVR)
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Edwards Lifesciences
Conditions:
Aortic Stenosis
Aortic Valve Stenosis
Eligibility:
All Genders
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 In...
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 t...
Eligibility Criteria
Inclusion
- 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
- CT demonstrating leaflet thrombosis or hypoattenuated leaflet thickening (HALT)
Key Trial Info
Start Date :
August 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 20 2025
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04827238
Start Date
August 30 2021
End Date
June 20 2025
Last Update
July 24 2025
Active Locations (9)
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1
PIMA Heart Centre
Tucson, Arizona, United States, 85712
2
Tenet Health
Boca Raton, Florida, United States, 33484
3
eCommunity
Indianapolis, Indiana, United States, 46256
4
Community Hospital
Munster, Indiana, United States, 46321