Detection of a heart event via Merlin.net PCN / detection of a heart event via home monitoring
Conditions
Interventions
ICD / CRT-D implantation before actual start of the trial.
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| * % 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. | — |
Countries
Netherlands
Outcome results
None listed