Brief Title
Standardized Invasive Hemodynamics for Elevated Gradients Post TAVR
Official Title
Standardized Invasive Hemodynamics for Monitoring Acute and Long Term Valve Performance in Patients With Elevated Gradients Post Transcatheter Aortic Valve Replacement
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.
Study Type
Observational
Primary Outcome
Transaortic valve gradients
Secondary Outcome
Total procedure time
Condition
Aortic Stenosis
Intervention
Standardized Invasive Hemodynamics
Study Arms / Comparison Groups
Patients with Elevated Gradients Post Transcatheter Aortic Valve Replacement
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
50
Start Date
March 26, 2021
Completion Date
December 31, 2021
Primary Completion Date
September 30, 2021
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)
Gender
All
Ages
N/A - N/A
Contacts
David Wood, MD, 604-838-1081, [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT04827238
Organization ID
H21-00824
Responsible Party
Principal Investigator
Study Sponsor
University of British Columbia
Collaborators
Edwards Lifesciences
Study Sponsor
David Wood, MD, Principal Investigator, University of British Columbia
Verification Date
March 2021