Primary safety endpoints
|
All-cause mortality
|
0 (0)
|
0 (0)
|
0 (0)
|
Myocardial infarction
|
0 (0)
|
0 (0)
|
0 (0)
|
Disabling stroke
|
0 (0)
|
0 (0)
|
0 (0)
|
Life-threatening bleeding
|
0 (0)
|
0 (0)
|
0 (0)
|
VARC-3 endpoints*
|
Valve-related mortality
|
0 (0)
|
0 (0)
|
0 (0)
|
All strokes
|
0 (0)
|
0 (0)
|
0 (0)
|
Neurological dysfunctions
|
0 (0)
|
0 (0)
|
0 (0)
|
All bleeding
|
0 (0)
|
0 (0)
|
0 (0)
|
Major vascular complications
|
1 (7.69)
|
0 (0)
|
0 (0)
|
Minor vascular complications
|
0 (0)
|
0 (0)
|
0 (0)
|
Cardiac complications
|
0 (0)
|
0 (0)
|
0 (0)
|
Permanent pacemaker implant
|
1 (7.69)
|
0 (0)
|
0 (0)
|
Bioprosthetic valve dysfunction
|
0 (0)
|
0 (0)
|
0 (0)
|
Structural valve deterioration
|
0 (0)
|
0 (0)
|
0 (0)
|
Reoperations/reinterventions on the study valve
|
0 (0)
|
0 (0)
|
0 (0)
|
Acute kidney injury
|
0 (0)
|
0 (0)
|
0 (0)
|
Major paravalvular leak (moderate or severe)
|
0 (0)
|
0 (0)
|
0 (0)
|
Major aortic regurgitation (moderate or severe)
|
1 (7.69)
|
1 (7.69)
|
0 (0)
|
Values are n (%). *Study endpoints are defined according to the VARC-3 guidelines16. VARC: Valve Academic Research Consortium
|