Outcomes
RLS
ADVERSE EVENTS, SECONDARY
The primary outcome was rate of RLS detection with TTE and raTCD in the intent to scan (ITS) cohort, which included site assessment of TTE (eg, local clinical interpretation). The primary safety outcome was any serious device-related adverse events. The key prespecified secondary outcome was rate of detection of large RLS on TTE and raTCD. The other prespecified secondary outcomes, including rate of absence of transtemporal windows and device performance parameters, are in the 