Status:

NOT_YET_RECRUITING

Health App Data Collection Study

Lead Sponsor:

Abbott Medical Devices

Collaborating Sponsors:

Huntsville Hospital Health System

Conditions:

Cardiac Disease

Eligibility:

All Genders

18+ years

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 monito...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2027

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT06595615

Start Date

March 1 2025

End Date

December 1 2027

Last Update

January 14 2025

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