NCT03518658

BlueSync Field Evaluation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 257 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this field evaluation is to collect and evaluate information related to CareLink transmission compliance as well as patient perceived benefit of BlueSync™ and the health care provider perception of the value of BlueSync™ and satisfaction with BlueSync™.

Detailed description

The primary goal is to learn how many CareLink quarterly scheduled transmissions are completed within a prescribed time period to assess CareLink scheduled transmission compliance. The evaluation will also assess adoption to remote monitoring, patient perceived benefit of BlueSync™ (how patients interact with the smart device application) and health care provider perception of the value of BlueSync™ and satisfaction with BlueSync™ (benefits experienced by clinicians that use BlueSync™). This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CRF 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CRF 11.24 and 11.44).

Conditions

• Bradycardia

Interventions

Type	Name	Description
OTHER	Evaluation Group	Patient receiving exposure to the MyCareLink Heart App during device pairing
OTHER	Control Group (Historical)	Patients receiving exposure to the CareLink Monitor 2490 (Excluding wireless model 2490C). The patients' data will be extracted from Medtronic de-identified CareLink™ database.

Timeline

• Start date: 2018-04-02
• Primary completion: 2019-12-29
• Completion: 2019-12-29
• First posted: 2018-05-08
• Last updated: 2021-05-06
• Results posted: 2021-05-06

Locations

20 sites across 4 countries: United States, France, Italy, United Kingdom