Table 3.
Safety endpoints
| Safety analysis set (N = 1007) | ||||
|---|---|---|---|---|
| n (%) | 95% CI | Device-related (n) |
Procedure-related (n) |
|
| Primary safety endpoints | 9 (0.9) | 0.4–1.7 | ||
| Cardiac tamponade/perforation | 3 (0.3) | Related (3) | Related (3) | |
| Major vascular access Complication/bleeding | 3 (0.3) | Not related (3) | Related (3) | |
| Pericarditis/pericardial effusion | 2 (0.2) | Not related (2) | Related (1) Not related (1) |
|
| Pulmonary oedema (respiratory insufficiency) | 1 (0.1) | Not related (1) | Not related (1) | |
| Atrio-oesophageal fistula | 0 (0.0) | |||
| Death | 0 (0.0) | |||
| Diaphragmatic paralysis | 0 (0.0) | |||
| Heart block | 0 (0.0) | |||
| Myocardial infarction | 0 (0.0) | |||
| Pneumothorax | 0 (0.0) | |||
| PV stenosis | 0 (0.0) | |||
| Stroke/cerebrovascular accident | 0 (0.0) | |||
| Thromboembolism | 0 (0.0) | |||
| Transient ischaemic attack | 0 (0.0) | |||
Total population (N = 1007).
Device-related primary adverse events were cardiac tamponade/perforation in three patients. Procedure-related primary adverse events were cardiac tamponade/perforation in three patients, major vascular access complication/bleeding in three patients, and pericarditis/pericardial effusion in one patient.