Table 3. Major adverse events in all enrolled patients.

	30 days n (%)	6 months n (%)	1 year n (%)
Primary safety composite endpoint*	2 (4.4%)	7 (15.6%)	8 (17.8%)
Death	0 (0.0%)	3 (6.7%)	5 (11.3%)
Cardiovascular	0 (0.0%)	3 (6.7%)	5 (11.3%)
Non-cardiovascular	0 (0.0%)	0 (0.0%)	0 (0.0%)
Stroke	0 (0.0%)	1 (2.3%)	1 (2.3%)
Myocardial infarction	0 (0.0%)	1 (2.3%)	1 (2.3%)
Mitral surgery/intervention	0 (0.0%)	1 (2.3%)	1 (2.3%)
Cardiac effusion/tamponade	1 (2.2%)	1 (2.2%)	1 (2.2%)
Renal failure	1 (2.2%)	3 (6.8%)	3 (6.8%)
*Death, stroke, myocardial infarction, cardiac effusion/tamponade, device-related cardiac surgery, renal failure.