Cardiac DiseaseNCT06595615
Health App Data Collection Study
An observational study of Cardiac Disease, run by Abbott Medical Devices at 1 site in United States.
Trial summary
Utilization of additional wearable data to improve clinical outcome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- cardiovascular implantable electronic devices
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients indicated for cardiac implantable medical devices
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Utilization of additional wearable data to improve clinical outcome
Read the 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.
- Conditions
- Cardiac Disease
- Being tested
- cardiovascular implantable electronic devices
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiovascular implantable electronic devicesDevice
Standard of care patients indicated for the devices
What is being measured
The primary outcome is the main question the study is designed to answer.
Acquisition of additional health data using patient App
Health data acquisition via an app from multiple wearables and externals.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Apr 2025
- Primary completionJan 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Huntsville Hospital Health System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595615
- Sponsor's protocol ID
- 10470
- Status last verified
- Apr 2026
- First submitted
- 27 Aug 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health App Data Collection Study
- ClinicalTrials.gov ID
- NCT06595615
- Acronym / sponsor ID
- 10470
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Huntsville Hospital Health System
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients indicated for cardiac implantable medical devices
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiovascular implantable electronic devicesStandard of care patients indicated for the devices | Device | – |
Primary outcome
Acquisition of additional health data using patient App
Time frame: 12 months
Health data acquisition via an app from multiple wearables and externals.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by Abbott Medical Devices at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acquisition of additional health data using patient App (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.