Health App Data Collection Study

NCT ID: NCT06595615

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-31

Study Completion Date

2027-12-31

Brief Summary

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Utilization of additional wearable data to improve clinical outcome

Detailed Description

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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.

Conditions

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Cardiac Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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cardiovascular implantable electronic devices

Standard of care patients indicated for the devices

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huntsville Hospital Health System

OTHER

Sponsor Role collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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JONG GILL

Role: CONTACT

2134465468

Other Identifiers

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10470

Identifier Type: -

Identifier Source: org_study_id

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