BlueSync Field Evaluation
1 other identifier
observational
257
4 countries
20
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™.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2018
CompletedFirst Submitted
Initial submission to the registry
April 20, 2018
CompletedFirst Posted
Study publicly available on registry
May 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2019
CompletedResults Posted
Study results publicly available
May 6, 2021
CompletedMay 6, 2021
April 1, 2021
1.7 years
April 20, 2018
January 29, 2021
April 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Acute CareLink Transmission Success
Scheduled transmissions in the first month after enrollment
Study Arms (2)
Evaluation Group
Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App
Control Group
Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C)
Interventions
Patient receiving exposure to the MyCareLink Heart App during device pairing
Patients receiving exposure to the CareLink Monitor 2490 (Excluding wireless model 2490C). The patients' data will be extracted from Medtronic de-identified CareLink™ database.
Eligibility Criteria
Patients at hospitals and clinics specializing in the implant and followup of pacemakers and CRT-P devices using remote monitoring
You may qualify if:
- 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
You may not qualify if:
- Patient unwilling to complete required surveys during 12-month evaluation period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Stanford Universithy
Palo Alto, California, 94305, United States
Hartford Hosital
Hartford, Connecticut, 06102, United States
Daytona Heart Group
Daytona Beach, Florida, 32114, United States
Cardiovascular Institutes of Orland0
Orlando, Florida, 32822, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
CentraCare
Saint Cloud, Minnesota, 56303, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
Cone Health
Greensboro, North Carolina, 27401, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Mount Carmel
Columbus, Ohio, 43213, United States
East Tennessee Consultants
Knoxville, Tennessee, 37934, United States
CHU Bordeaux
Bordeaux, France
CHI Toulouse
Toulouse, France
Istituto clinico Città Studi
Milan, Italy
Ospedale Sacro Cuore
Negrar, 37024, Italy
Provincia Religiosa San Pietro Di Roma
Rome, Italy
Sandwell and West Birmingham Hospitals
Birmingham, B71 4HJ, United Kingdom
Manchester Royal Infirmary
Manchester, M139WC, United Kingdom
Southampton
Southampton, SO166YD, United Kingdom
University Hospital of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Keith Holloman
- Organization
- CRHF Clinical
Study Officials
- PRINCIPAL INVESTIGATOR
Khaldoun Trajki, MD
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2018
First Posted
May 8, 2018
Study Start
April 2, 2018
Primary Completion
December 29, 2019
Study Completion
December 29, 2019
Last Updated
May 6, 2021
Results First Posted
May 6, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share
There are not plans to share IPD with other researchers