Health App Data Collection Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cardiovascular implantable electronic devices.
- Who it may be relevant to
- Registry conditions: Cardiac Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 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.
Interventions
- Device cardiovascular implantable electronic devices
Standard of care patients indicated for the devices
Primary outcome measures
- Acquisition of additional health data using patient App [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Heart Center Research — Huntsville
Identifiers
NCT: NCT06595615 · 10470