What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Left atrial appendage Occlusion, or DOAC. The registry lists allocation as randomized. Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and cardioembolic stroke due to AF is its major complication.
They plan to enroll about 482 people at 34 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.
Official title (unrewritten)
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic StrokE Despite Anticoagulation Therapy
Interventions: Left atrial appendage Occlusion, DOAC
Primary outcome (registry wording): Composite of recurrent ischemic stroke, systemic embolism, or cardiovascular death (whatever comes first).