The Patient Meets ACC/AHA/ESC Guidelines for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) Device
Conditions
Keywords
ICD, CRTD, Remote Care
Brief summary
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.
Interventions
DEVICEImplantation of an ICD/CRT-D device
The Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) device and leads are not the devices being evaluated in this investigation.
DEVICEMerlin.NET PCN
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
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient meets ACC/AHA/ESC guidelines for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-D) device * The 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) * The patient has a life expectancy of greater than 12 months (based on the physician's discretion). * The patient is mentally capable to participate in the investigation (based on the physician's discretion). * The patient is 18 years of age or older
Exclusion criteria
* The patient is being actively considered for cardiac transplantation. * The patient has primary valvular disease that has not been corrected. * The patient had a myocardial infarction within the last month * The patient had unstable angina within the last month. * The patient has had Coronary Artery Bypass Grafting (CABG) within the last month. * The patient had a Percutaneous Coronary Angioplasty (PTCA) within the last month. * The patient is pregnant.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| The changes over one year in the Hospital Anxiety and Depression Scale (HADS) for the two different randomization arms | 2 years |
Countries
Germany, United Kingdom
Outcome results
None listed