BlueSync Field Evaluation

Medtronic

Status: Completed

Conditions: Bradycardia

Treatments: Other: Control Group (Historical); Other: Evaluation Group

Study type: Observational

Funder types: Industry

Identifiers

NCT03518658

BlueSync Field Evaluation

Details and patient eligibility

About

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™.

Full 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).

Enrollment: 257 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient will be/has been implanted with an Azure™ or Percepta™, Serena™, Solara™ CRT-P device compatible with BlueSync™ (both new and replacement devices are allowed)
• Patient must own a smart device (Smartphone or tablet) that meets system requirements and be willing to use during evaluation period
• Patient must be able to complete the required 12-month follow-up after enrollment
• Patients must be of legal age according to local law

Exclusion criteria

• Patient unwilling to complete required surveys during 12-month evaluation period

Trial design

257 participants in 2 patient groups

Evaluation Group

Description:

Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App

Treatment:

Other: Evaluation Group

Control Group

Description:

Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C)

Treatment:

Other: Control Group (Historical)