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…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint for the investigation is the time between the detection of
an event and the point in time when the physician or delegate takes a clinical
decision.
Detection of an event =
The time when the implanted device (ICD or CRT-D) triggers an alert. The alert
is based on a change in value outside the default or programmed limits.
Clinical decision =
When the physician or delegate determines if an action is required to follow-up
on the event; or an action is not required to follow-up on the event
Secondary outcome
* % of all events for which a clinical decision could be taken based on the
device data retrieved during the Remote Monitoring review.
* Physician or delegate time spent during in-clinic and remote follow up (both
protocol required scheduled and unscheduled follow ups) and daily remote
monitoring review.
Background summary
Previous studies have shown the effectiveness of the implantable cardioverter
defibrillator (ICD) in both primary and secondary prevention of sudden cardiac
death and have influenced the number of patients implanted with devices
significantly. This expanding population of patients with implantable cardiac
devices requires special care and regular follow up. The current guidelines
for the management of implanted device require interrogation and monitoring of
the device 2-4 times per year. With the latest generation of devices,
clinicians are able to follow up (FU) their patients with ICDs remotely, with
fewer in-clinic consultations. Several studies have shown that this may result
in more efficient FU with cost-savings for the health care payer
Besides allowing remote follow up, the newest devices also have the capability
of automatic alerting of silent but potentially dangerous events.
In the literature it is clear that an automatic alerting capability could
provide early detection and notification of the clinician of these silent
events. However, there are few data available on the positive effect of
automatic alerts on the time to clinical decision making.
This investigation is developed to investigate if the detection of silent
cardiac events will occur earlier with the daily alerts notification feature of
St Jude Medical (Remote monitoring) and if so, if it will lead to more timely
management. Early detection and resolution of these events could then improve
patient care.
Study objective
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.
This investigation is a randomized, prospective, open, parallel, multicenter
design.
Study design
Randomization
* Randomization is stratified by center and by implanted device (ICD or CRT-D).
* Patients are randomized in a 1:1 fashion to either the control or remote
monitoring group.
* Control Group:
The monitoring of alerts (system integrity and diagnostics) will be programmed
ON in the patient*s implanted device. The Remote Monitoring Direct Alerts will
be programmed OFF in the Merlin.Net PCN.
* Remote Monitoring Group:
The monitoring of alerts (system integrity and diagnostic) will be programmed
ON in the patient*s implanted device. The Remote Monitoring Direct Alerts will
be turned ON in the Merlin.Net PCN.
Intervention
ICD / CRT-D implantation before actual start of the trial.
Study burden and risks
Participation in the trial does not expose patient to additional risks
Standaardruiter 13
3905 PT Veenendaal
NL
Standaardruiter 13
3905 PT Veenendaal
NL
Listed location countries
Age
Inclusion criteria
- Patient meets ACC/AHA/ESC guidelines for implantable cardioverter defibrillator (ICD) of cardiac resynchronization therapy (CRT-D) device
- Patient is recently (*2 weeks) implanted with a SJM device compatible with the Merlin.net* PCN (inclusive of upgrade from ICD to CRT-D or an implantable pulse generator change)
- Patient has a life expectancy of greater than 12 months (based on the physician's discretion)
- Patient is mentally capable to participate in the investigation (based on the physician's dicretion)
- Patient is 18 years of age or older
Exclusion criteria
- Patient is being actively considered for cardiac transplantation
- Patient has primary valvular disease that has not been corrected
- Patient had a myocardial infarction within the last month
- Patient had unstable angina within the last month
- Patient has had Coronary Artery Bypass Grafting (CABG) within the last month
- Patient had a Percutaneous Coronary Angioplasty (PTCA) within the last month
- Patient is pregnant
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31122.098.10 |