Health App Data Collection Study

April 2, 2026 updated by: Abbott Medical Devices
Utilization of additional wearable data to improve clinical outcome

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients indicated for cardiac implantable medical devices

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acquisition of additional health data using patient App
Time Frame: 12 months
Health data acquisition via an app from multiple wearables and externals.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Collaborators

Huntsville Hospital Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

September 11, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10470 (Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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