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Trial record 1 of 1 for:    BlueSync
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BlueSync Field Evaluation

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ClinicalTrials.gov Identifier: NCT03518658
Recruitment Status : Completed
First Posted : May 8, 2018
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief 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™.

Condition or disease Intervention/treatment
Bradycardia Other: Evaluation Group Other: Control Group

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™).

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Study Type : Observational
Actual Enrollment : 252 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BlueSync Field Evaluation
Actual Study Start Date : April 2, 2018
Actual Primary Completion Date : December 29, 2019
Actual Study Completion Date : December 29, 2019

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
Patients receiving exposure to the CareLink Monitor 2490 (Excluding wireless model 2490C)




Primary Outcome Measures :
  1. Carelink compliance to transmission schedule [ Time Frame: Change in scheduled transmissions between 3 and 12 months after enrollment ]
    CareLink transmission compliance (adherence to scheduled transmission), the primary objective is to compare the proportions 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).


Secondary Outcome Measures :
  1. Acute CareLink transmission compliance [ Time Frame: Two scheduled transmissions at 2 weeks and 4 weeks after enrollment ]
    Proportion 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518658


Locations
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Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Principal Investigator: Khaldoun Trajki, MD The Cleveland Clinic
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT03518658    
Other Study ID Numbers: 500
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are not plans to share IPD with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
remote monitoring
transmission compliance
patient engagement
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes