BIOTRONIK Evia DR, Техническое руководство

Страница: 54 / 183

46 Evia Technical Manual
Primary Endpoints
The purpose of primary endpoint 1 (HM efficacy) was to
compare the number of in-office ICD follow-ups for patients in
Group 1 (HM) to the conventional, calendar-based method of
ICD follow-up as in Group 2 (Control).
The purpose of the primary endpoint 2 (safety) was to compare
the Safety Event Rate (SER), which includes death, incidence of
strokes and events requiring surgical interventions (e.g. device
explants or lead revision) between the two groups.
Secondary Endpoints
The purpose of secondary endpoint 1 was to compare AF, VT
and VF events between Group 1 and Group 2 in terms of the
number, categories, and detection time relative to onset.
Inclusion Criteria
To support the objectives of this investigation, the inclusion
criteria at the time of patient enrollment for this investigational
study included the following requirements:
•
Implanted within the last 45 days or being considered for
implant with a BIOTRONIK ICD with Home
Monitoring/IEGM-Online technology
•
Able to utilize the HM system throughout the study
•
Ability to give informed consent
•
Geographically stable and able to return for regular
follow-ups for fifteen (15) months
•
At least 18 years old
Exclusion Criteria
To support the objectives of this investigation, the exclusion
criteria at the time of patient enrollment included the following
requirements:
•
Patients who do not fulfill all inclusion criteria
•
Patients who are pacemaker dependent
•
Currently enrolled in any other cardiac clinical
investigation.