BlueSync Field Evaluation

Completed

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™.

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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Evaluation Group	Evaluation Group	Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App
Control Group	Control Group (Historical)	Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C)

Primary Outcome Measures

Name	Time	Method
Chronic CareLink Transmission Success	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.

Secondary Outcome Measures

Name	Time	Method
Acute CareLink Transmission Success	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.

Locations (20): Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Stanford Universithy
🇺🇸
Palo Alto, California, United States
Hartford Hosital
🇺🇸
Hartford, Connecticut, United States
Daytona Heart Group
🇺🇸
Daytona Beach, Florida, United States
Cardiovascular Institutes of Orland0
🇺🇸
Orlando, Florida, United States
CentraCare
🇺🇸
Saint Cloud, Minnesota, United States
The Valley Hospital
🇺🇸
Ridgewood, New Jersey, United States
Cone Health
🇺🇸
Greensboro, North Carolina, United States
Mount Carmel
🇺🇸
Columbus, Ohio, United States
East Tennessee Consultants
🇺🇸
Knoxville, Tennessee, United States
CHU Bordeaux
🇫🇷
Bordeaux, France
Ospedale Sacro Cuore
🇮🇹
Negrar, Italy
Sandwell and West Birmingham Hospitals
🇬🇧
Birmingham, United Kingdom
Provincia Religiosa San Pietro Di Roma
🇮🇹
Rome, Italy
Manchester Royal Infirmary
🇬🇧
Manchester, United Kingdom
University Hospital of North Midlands NHS Trust
🇬🇧
Stoke-on-Trent, United Kingdom
CHI Toulouse
🇫🇷
Toulouse, France
Istituto clinico Città Studi
🇮🇹
Milan, Italy
Southampton
🇬🇧
Southampton, United Kingdom
University of Kansas Medical Center
🇺🇸
Kansas City, Kansas, United States