St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment or replace routine scheduled in-clinic visits. This investigation is designed with the hypothesis that detection of events (system integrity and diagnostic related) through Direct Alerts™ via Remote Monitoring allow clinicians an earlier opportunity to address and resolve events and may therefore improve patient care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
220
The Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) device and leads are not the devices being evaluated in this investigation.
The Merlin.Net™ PCN is a dedicated computer system that connects physicians to patients outside of the clinic setting by centralizing data from remote transmissions, implant procedures and in-clinic follow-ups into single location with easy export to Electronic Health Record (EHR) systems
Dr. Ralph Bosch
Ludwigsburg, Germany
Freeman Hospital
Newcastle, United Kingdom
time between the detection of an event and the point in time when the physician or delegate takes a clinical decision
Time frame: 2 years
The sufficiency of the device data retrieved through the Remote Monitoring feature to make a clinical decision
Time frame: 2 years
The physician or delegate time required for remote follow up as compared to in-clinic follow up
Time frame: 2 years
The changes over one year in the Hospital Anxiety and Depression Scale (HADS) for the two different randomization arms
Time frame: 2 years
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