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OpenTrials
Enrolling by Invitation

NCT Number: NCT06595615

Health App Data Collection Study

Utilization of additional wearable data to improve clinical outcome

Enrolling by Invitation

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Center Research

Huntsville, Alabama, 35801, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiovascular implantable electronic devices

Device

Standard of care patients indicated for the devices

Primary outcomes

  1. Acquisition of additional health data using patient App

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Collaborators

  • Huntsville Hospital Health System

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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