|Category I: Neurological Injury as Procedural and Long-Term Safety Measure||Category II: Neurological Injury as Procedural Efficacy Measure||Category III: Neurological Injury as Procedural Safety and Long-Term Efficacy Measure|
|Device/procedure type||Devices or procedures with inherent iatrogenic embolic risk, for example:||Devices or procedures designed to prevent iatrogenic or spontaneous acute neurological injury, for example:||Devices or procedures with inherent iatrogenic embolic risk and designed for prevention of spontaneous long-term risk, for example:|
|Suggested endpoints||Early and long-term safety endpoints||Early efficacy endpoints||Early safety and long-term efficacy endpoints|
|Clinical assessments||Neurological and functional impairment||Neurological and functional impairment||Neurological and functional impairment|
|Quality of life||Quality of life||Quality of life|
3D = 3-min diagnostic; ACAS = asymptomatic carotid atherosclerosis study; CABG = coronary artery bypass graft surgery; CAM = confusion assessment method; CT = computed tomography; ICU = intensive care unit; LAA = left atrial appendage; LV = left ventricular; MoCA = Montreal Cognitive Assessment; MRI = magnetic resonance imaging; MVR = mitral valve replacement; NIHSS = National Institutes of Health Stroke Scale; PFO = patent foramen ovale; QVSFS = Questionnaire for Verifying Stroke Free Status; TAVR = transcatheter aortic valve replacement; TCD = transcranial Doppler ultrasound; other abbreviations as in Table 1.