Health App Data Collection Study

Abbott

Status: Not yet enrolling

Conditions: Cardiac Disease

Treatments: Device: cardiovascular implantable electronic devices

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06595615

10470 (Other Identifier)

Details and patient eligibility

About

Utilization of additional wearable data to improve clinical outcome

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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