Table 1.
Trial Name | Enrollment Period | No. Sites & Countries | No. of Participants | Inclusion criteria | Control group | Primary (1°), Secondary (2°), Post-hoc Outcomes | |
---|---|---|---|---|---|---|---|
CRYSTAL AF, 201411 | 6/2009 – 4/2012 | 55 sites, Europe, Canada, US | ILR: 221 Control: 220 |
≥40 yrs, CS | ECG, Holter, event monitor | 1°: AF at 6-mo. | 2°: AF at 12-mo., stroke/TIA, change in OAC use |
STROKE-AF , 202112 | 5/2015–11/2017 | 33 sites, US | ILR: 242 Control: 250 |
≥60 yrs LAA or lacunar |
ECG, Holter, event monitor, MCT | 1°: AF at 12-mo. | 2°: AF at 36-mo. Post-hoc: AF at 6-mo., stroke/TIA, OAC use |
PER DIEM , 202113 | 4/2016–7/2019 | 3 sites, Canada | ILR: 150 Control: 150 |
≥18 yrs All strokes |
30-day external loop recorder | 1°: AF at 12-mo. | 2°: AF or death, time to AF, stroke/TIA, ICH, MB ≤12-mo. |
Abbreviations: AF, atrial fibrillation; CRYSTAL AF, Cryptogenic Stroke and Underlying Atrial fibrillation; CS, cryptogenic stroke; ECG, electrocardiogram; ICH, intracranial hemorrhage; ILR, implantable loop recorder; LAA, large-artery atherosclerosis; MB, major bleeding; MCT, mobile cardiac telemetry; PER DIEM, Post-Embolic Rhythm Detection with Implantable vs External Monitoring; OAC, oral anticoagulation; STROKE-AF, Stroke of Known Cause and Underlying Atrial Fibrillation; TIA, transient ischemic attack; US, United States; Yrs, years.