Cardiac Disease
Conditions
Brief summary
Utilization of additional wearable data to improve clinical outcome
Detailed description
In addition to information available from cardiac implantable medical devices, health related data available from commercially approved wearables and devices such as Apple watch, blood pressure monitor and scales could be used to improve predictive analytics of impending clinical events. This study is to merge implantable medical device data with wearable data to evaluate the added benefit of extra data.
Interventions
DEVICEcardiovascular implantable electronic devices
Standard of care patients indicated for the devices
Sponsors
Abbott Medical Devices
Huntsville Hospital Health System
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients are willing to be compliant with daily measurements required 18 years of age or older * Patients who have been implanted with ABT CRT-D devices connected to Merlin.net * Patients who had at least one HF clinical event during past 12 calendar months * Must provide written informed consent prior to the commencement of this clinical feasibility study * Patients are willing to be compliant with daily measurements required
Exclusion criteria
* Pregnant and/or lactating mothers will be excluded from the study or have a plan to be pregnant in the next 12 months * Patients with a life expectancy less than the duration of the study, as per clinician's discretion. * Patients who will not be able to complete the daily survey questions due to inability to read
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acquisition of additional health data using patient App | 12 months | Health data acquisition via an app from multiple wearables and externals. |
Countries
United States
Outcome results
None listed