Health App Data Collection Study

Abbott Medical Devices0 sites80 target enrollmentMarch 2025

ConditionsCardiac Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiac Disease
Sponsor: Abbott Medical Devices
Enrollment: 80
Primary Endpoint: Acquisition of additional health data using patient App
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2025

End Date

December 2027

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

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