BlueSync Field Evaluation

April 13, 2021 updated by: Medtronic Cardiac Rhythm and Heart Failure
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™.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

257

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU Bordeaux
      • Toulouse, France
        • CHI Toulouse
  • Italy
      • Milan, Italy
        • Istituto Clinico Città Studi
      • Negrar, Italy, 37024
        • Ospedale Sacro Cuore
      • Rome, Italy
        • Provincia Religiosa San Pietro Di Roma
  • United Kingdom
      • Birmingham, United Kingdom, B71 4HJ
        • Sandwell and West Birmingham Hospitals
      • Manchester, United Kingdom, M139WC
        • Manchester Royal Infirmary
      • Southampton, United Kingdom, SO166YD
        • Southampton
      • Stoke-on-Trent, United Kingdom
        • University Hospital of North Midlands NHS Trust
  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Stanford Universithy
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hosital
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Daytona Heart Group
      • Orlando, Florida, United States, 32822
        • Cardiovascular Institutes of Orland0
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Minnesota
      • Saint Cloud, Minnesota, United States, 56303
        • CentraCare
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Cone Health
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43213
        • Mount Carmel
    • Tennessee
      • Knoxville, Tennessee, United States, 37934
        • East Tennessee Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients at hospitals and clinics specializing in the implant and followup of pacemakers and CRT-P devices using remote monitoring

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Evaluation Group
Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App
Other: Evaluation Group
Patient receiving exposure to the MyCareLink Heart App during device pairing
Control Group
Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic CareLink Transmission Success
Time Frame: Scheduled transmissions between 1 and 12 months after enrollment/CareLink activation

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
Time Frame: Scheduled transmissions in the first month after enrollment

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Principal Investigator: Khaldoun Trajki, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2018

Primary Completion (Actual)

December 29, 2019

Study Completion (Actual)

December 29, 2019

Study Registration Dates

First Submitted

April 20, 2018

First Submitted That Met QC Criteria

May 7, 2018

First Posted (Actual)

May 8, 2018

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BlueSync Field Evaluation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There are not plans to share IPD with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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