3 results
Demonstrate that the remote management system (Carelink, study group) reduces the time from device detected event onset to clinicaldecision for arrhythmias, cardiovascular disease progression,and system issues compared to patients receiving only in-…
The primary objective is to demonstrate the efficacy using 2 co-primary endpoints (as measured by thechanges from baseline to the end of Week 16 in Western Ontario and McMaster UniversityOsteoarthritis Index [WOMAC] pain and physical function…
Primary ObjectiveTo generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints Secondary…