Table 12.

Non-AF recurrence--related endpoints for reporting in AF ablation trials

Stroke and bleeding endpoints	Definitions/Details
Stroke (2014 ACC/AHA Key Data Elements)	An acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Symptoms or signs must persist ≥24 hours, or if documented by CT, MRI or autopsy, the duration of symptoms/signs may be less than 24 hours. Stroke may be classified as ischemic (including hemorrhagic transformation of ischemic stroke), hemorrhagic, or undetermined. Stroke disability measurement is typically performed using the modified Rankin Scale (mRS).
Transient ischemic attack (2014 ACC/AHA Key Data Elements)	Transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia without acute infarction and with signs and symptoms lasting less than 24 hours.
Major bleeding (ISTH definition)	Fatal bleeding AND/OR symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, or intramuscular with compartment syndrome AND/OR bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of blood.
Clinically relevant nonmajor bleed (ISTH definition)	An acute or subacute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response such that it leads to one of the following: hospital admission for bleeding; physician-guided medical or surgical treatment for bleeding; change in antithrombotic therapy (including interruption or discontinuation).
Minor bleeding (ISTH definition)	All nonmajor bleeds. Minor bleeds are further divided into clinically relevant and not.
Incidence and discontinuation of oral anticoagulation	The number of patients receiving oral anticoagulation and the type of oral anticoagulation should be documented at the end of follow-up. If patients have their oral anticoagulation discontinued, the number of patients discontinuing, the timing of discontinuation, and the reasons for discontinuation of oral anticoagulation, as well as the clinical characteristics and stroke risk profile of the patients should be reported.

AF = atrial fibrillation; CT = computed tomography; MRI = magnetic resonance imaging.