BlueSync Field Evaluation

Study Overview
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Brief Summary
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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
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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).

Official Title
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BlueSync Field Evaluation

Conditions
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Bradycardia

Intervention / Treatment
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* Other: Evaluation Group
* Other: Control Group (Historical)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Evaluation Group<br>Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App | Other: Evaluation Group<br>* Patient receiving exposure to the MyCareLink Heart App during device pairing<br>|
| Control Group<br>Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C) | Other: Control Group (Historical)<br>* Patients receiving exposure to the CareLink Monitor 2490 (Excluding wireless model 2490C). The patients' data will be extracted from Medtronic de-identified CareLink™ database.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic CareLink Transmission Success | To assess CareLink transmission compliance (adherence to scheduled transmission), the primary objective is to compare the percentages of the CareLink quarterly scheduled transmissions that are completed within the prescribed window during the 12-month follow-up after the baseline visit in the CareLink Database between the evaluation patients who use the MyCareLink Heart™ (MCL) app and patients with low power devices and CareLink monitors 2490 (excluding wireless model 2490C). For both patient groups, all scheduled transmissions between 1 and 12 months after enrollment/CareLink activation were included. The results reflect the total percentage of completed transmissions pooled across subjects taking into account that there were several transmissions per subject. A correlated data method was required for the analysis. A 95% confidence interval based on generalized estimating equations for binomial distribution was calculated for the percentage of completed scheduled transmissions. | Scheduled transmissions between 1 and 12 months after enrollment/CareLink activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute CareLink Transmission Success | To assess acute CareLink transmission compliance (adherence to scheduled transmission), the secondary objective is to characterize the percentage of the CareLink bi-weekly scheduled transmissions that are completed within the prescribed window during the 1-month follow-up after the baseline visit in the CareLink Database via the MCL Heart™ app. All scheduled transmissions within the first month after enrollment were included in the analysis. The results reflect the total percentage of completed transmissions pooled across all subjects taking into account that there were several transmissions per subject. A correlated data method was required for the analysis since there were several transmissions per subject. A two-sided 95% confidence interval based on generalized estimating equations (GEE) for binomial distribution was calculated for the percentage of completed scheduled transmissions. | Scheduled transmissions in the first month after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remote monitoring, transmission compliance, patient engagement