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| ID | Type | Description | Link |
|---|---|---|---|
| YSI-002 | Other Identifier | Yale |
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| Name | Class |
|---|---|
| Anteris Technologies Corporation | UNKNOWN |
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The purpose of this study is to help understand how the replacement valve functions over time, both at rest and during exercise.
The objective of this single-center registry is to evaluate prosthetic valve hemodynamics and function over time in patients undergoing clinically indicated transcatheter aortic valve replacement (TAVR) for symptomatic severe aortic stenosis. Specific goals include:
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| Measure | Description | Time Frame |
|---|---|---|
| TransAortic Valve Gradient during exercise at 12 months post-TAVR | TransAortic Valve Gradient (mmHg) during exercise as assessed by the Echocardiographic Core Laboratory and summarized as peak and mean. | 12 months post-TAVR |
| Measure | Description | Time Frame |
|---|---|---|
| Change in valve cusp thickness at rest | Change in valve cusp thickness (mm) at rest assessed using echocardiogram reported as absolute values and as changes. | baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR |
| Change in valve mobility at rest |
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Inclusion Criteria:
Exclusion Criteria:
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A minimum of 50 and up to 100 adults presenting with symptomatic severe aortic stenosis referred for clinically indicated TAVR at Yale New Haven Hospital who meet all eligibility criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Amit Vora, MD | Yale University | Principal Investigator |
| Alexandra J Lansky, MD | Yale University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Change in valve mobility at rest assessed using echocardiogram reported as absolute values and as changes. |
| baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR |
| Change in paravalvular leak at rest | Change in paravalvular leak at rest assessed using echocardiogram reported as absolute values and as changes. | baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR |
| Change in coefficient of contraction Effective Orifice Area (EOA)/Geometric Orifice Area (GOA) at rest | Change in coefficient of contraction EOA/GOA at rest assessed using echocardiogram reported as absolute values and as changes. | baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR |
| Change in Dimensionless Velocity Index (DVI) at rest | Change in DVI at rest assessed using echocardiogram reported as absolute values and as changes. | baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR |
| Change in energy loss coefficient at rest | Change in energy loss coefficient at rest assessed using echocardiogram reported as absolute values and as changes. | baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR |
| Change in EOA at rest | Change in EOA (cm2) at rest assessed using echocardiogram reported as absolute values and as changes. | baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR |
| Change in aortic valve gradient (peak and mean) at rest | Change in aortic valve gradient (mmHg) (peak and mean) at rest assessed using echocardiogram reported as absolute values and as changes. | baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR |
| Change in aortic valve velocity (peak and mean) at rest | Change in aortic valve velocity (m/s) (peak and mean) at rest assessed using echocardiogram reported as absolute values and as changes. | baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR |
| Change in Left Ventricle (LV) remodeling at rest | Change in LV remodeling at rest assessed using echocardiogram reported as absolute values and as changes. | baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR |
| Change in leaflet thickening at rest | Change in leaflet thickening at rest assessed using echocardiogram reported as absolute values and as changes. | baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR |
| Change in coaptation length at rest | Change in coaptation length (mm) at rest assessed using echocardiogram reported as absolute values and as changes. | baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR |
| Change in LV thickness at rest | Change in LV thickness (cm) at rest assessed using echocardiogram reported as absolute values and as changes. | baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR |
| Change in LV Global Longitudinal Strain at rest | Change in LV Global Longitudinal Strain (%) at rest assessed using echocardiogram reported as absolute values and as changes. | baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR |
| Change in Right Ventricular (RV) systolic velocity at rest | Change in RV systolic velocity (cm/s) at rest assessed using echocardiogram reported as absolute values and as changes. | baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR |
| Change in RV systolic pressure (RVSP) at rest | Change in RVSP (mmHg) at rest assessed using echocardiogram reported as absolute values and as changes. | baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR |
| Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) at rest | Change in TAPSE (mm) at rest assessed using echocardiogram reported as absolute values and as changes. | baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR |
| Change in aortic valve gradient (peak and mean) with exercise | Change in gradient (mmHg) (peak and mean) with exercise assessed using echocardiogram reported as absolute values and as changes. | 30 days, and 12 months post-TAVR |
| Change in aortic valve velocity (peak and mean) with exercise | Change in aortic valve velocity (m/s) (peak and mean) with exercise assessed using echocardiogram reported as absolute values and as changes. | 30 days and 12 months post-TAVR |
| Change in DVI with exercise | Change in DVI with exercise assessed using echocardiogram reported as absolute values and as changes. | 30 days and 12 months post-TAVR |
| Change in EOA with exercise | Change in EOA (cm2) with exercise assessed using echocardiogram reported as absolute values and as changes. | 30 days and 12 months post-TAVR |
| Change in RVSP with exercise | Change in RVSP (mmHg) with exercise assessed using echocardiogram reported as absolute values and as changes. | 30 days and 12 months post-TAVR |
| Change in exercise duration | Change in exercise duration (min) reported as absolute values and as changes. | 30 days and 12 months post-TAVR |
| Change in LV Global Longitudinal Strain with exercise | Change in LV Global Longitudinal Strain (%) with exercise assessed using echocardiogram reported as absolute values and as changes. | 30 days and 12 months post-TAVR |
| TAVR Device Success (Valve Academic Research Consortium [VARC]-defined) | TAVR Device Success evaluated post-procedure/pre-discharge during hospitalization approximatively 3 days, defined as: absence of procedural mortality AND correct positioning of a single prosthetic heart valve into the proper anatomical location AND intended performance of the prosthetic heart valve (defined as no prosthesis-patient mismatch [VARC-defined] and mean aortic valve gradient <20 mm Hg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation [VARC-defined] [site and Core Laboratory-reported]. | during hospitalization approximatively 3 days |
| Composite Safety Endpoints (VARC-3 defined) | Composite safety endpoint reported as a proportion of participants who died or experienced neurological events or life-threatening bleeding or acute kidney injury or coronary artery obstruction requiring intervention or major vascular complications or valve-related dysfunction requiring repeat procedure evaluated at 30 days and 12 months. | 30 days and 12 months post-TAVR |
| D014694 |
| Ventricular Outflow Obstruction |