Health App Data Collection Study

NCT06595615 | Not Yet Recruiting

• 1 other identifier: 10470
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Utilization of additional wearable data to improve clinical outcome

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (1)

• Acquisition of additional health data using patient App

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

  12 months

Interventions

cardiovascular implantable electronic devices DEVICE

Standard of care patients indicated for the devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients indicated for cardiac implantable medical devices

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Huntsville Hospital Health System: collaborator

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

JONG GILL

CONTACT

2134465468; john.gill1@abbott.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share