Defining Exercise Hemodynamics and Function After Transcatheter Aortic Valve Replacement (DEFINE-TAVR) Study.

Change in energy loss coefficient at rest

Change in energy loss coefficient at rest assessed using echocardiogram reported as absolute values and as changes.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 30 days and 12 months post-TAVR

Change in exercise duration

Change in exercise duration (min) reported as absolute values and as changes.

Time frame: 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.

Time frame: 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 \[VARC-defined\] \[site and Core Laboratory-reported\].

Time frame: 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.

Time frame: 30 days and 12 months post-TAVR