Health App Data Collection Study | NCT06595615

Studies
Health App Data Collection Study

NCT06595615

Sponsor

Abbott Medical Devices

Status

Enrolling by invitation

Last Update Posted

Apr 3, 2026Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Cardiac Disease

Interventions

cardiovascular implantable electronic devices

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 9, 2025Actual

Primary Completion Date

Jan 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Aug 27, 2024

First Submission Date that Met QC Criteria

Sep 11, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2026

Last Update Posted Date

Apr 3, 2026Actual

Name	Class
Huntsville Hospital Health System	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cardiovascular implantable electronic devices	Device	Standard of care patients indicated for the devices

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acquisition of additional health data using patient App	Health data acquisition via an app from multiple wearables and externals.	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients indicated for cardiac implantable medical devices

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heart Center Research		Huntsville	Alabama	35801	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided