Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct Alerts ON | Experimental | Direct Alerts in implantable device were turned on |
|
| Direct Alerts OFF | Active Comparator | Direct Alerts in implantable device were turned off |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of an ICD/CRT-D device | Device | The Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) device and leads are not the devices being evaluated in this investigation. |
| Measure | Description | Time Frame |
|---|---|---|
| time between the detection of an event and the point in time when the physician or delegate takes a clinical decision | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The sufficiency of the device data retrieved through the Remote Monitoring feature to make a clinical decision | 2 years | |
| The physician or delegate time required for remote follow up as compared to in-clinic follow up | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janet McComb, MD | Freeman Hospital Newcastle; UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Ralph Bosch | Ludwigsburg | Germany | ||||
| Freeman Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Merlin.NET PCN | Device | 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 |
|
|
| The changes over one year in the Hospital Anxiety and Depression Scale (HADS) for the two different randomization arms | 2 years |
| Newcastle |
| NE7 7DN |
| United Kingdom |