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
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.
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) |
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 |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Edwards Lifesciences |
United States, Canada,
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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