MedPath

Health App Data Collection Study

Not yet recruiting
Conditions
Cardiac Disease
Registration Number
NCT06595615
Lead Sponsor
Abbott Medical Devices
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
80
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Acquisition of additional health data using patient App12 months

Health data acquisition via an app from multiple wearables and externals.

Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath