Table 4.

Summary of PAEs, mITT analysis set (n = 137)^a

	n (%)
PAEs (≤7 days post-ablation)b	6 (4.4)c
Atrio-oesophageal fistula	0
Phrenic nerve paralysis (permanent)	0
PV stenosis	2 (1.5)
Cardiac tamponade/perforation	2 (1.5)
Stroke/cerebrovascular accident	1 (0.7)
Transient ischaemic attack	0
Major vascular access complication/bleeding	0
Thromboembolism	0
Myocardial infarction	0
Pericarditis	1 (0.7)
Heart block	0
Pulmonary oedema (respiratory insufficiency)	0
Vagal nerve injury/gastroparesis	0
Death (device or procedure related)	0

mITT, modified intent-to-treat; PAE, primary adverse event; PV, pulmonary vein.

^aOne patient in the mITT analysis set withdrew before the 3-month follow-up and had no PAE, and was thus excluded from the denominator of n = 137.

^bDevice- or procedure-related death, PV stenosis, and atrio-oesophageal fistula that occur at 7–90 days and cardiac tamponade/perforation occurring within 30 days post-ablation were also considered as PAEs. Phrenic nerve paralysis was considered a PAE if specified symptoms had not improved at the 3-month visit.

^cThe upper bound of the two-sided exact 95% confidence intervals is 9.3%, less than the prespecified performance goal of 12%.