Clinical trial NCT03518658: BlueSync Field Evaluation
Official title: BlueSync Field Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Keywords: remote monitoring
transmission compliance
patient engagement
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2018-05-08
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

Eligibility 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

Primary outcomes:
measure: Chronic CareLink Transmission Success
timeFrame: Scheduled transmissions between 1 and 12 months after enrollment/CareLink activation
Secondary outcomes:
measure: Acute CareLink Transmission Success
timeFrame: Scheduled transmissions in the first month after enrollment
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Universithy
state: California
city: Hartford
country: United States
facility: Hartford Hosital
state: Connecticut
city: Daytona Beach
country: United States
facility: Daytona Heart Group
state: Florida
city: Orlando
country: United States
facility: Cardiovascular Institutes of Orland0
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Saint Cloud
country: United States
facility: CentraCare
state: Minnesota
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Greensboro
country: United States
facility: Cone Health
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel
state: Ohio
city: Knoxville
country: United States
facility: East Tennessee Consultants
state: Tennessee
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Toulouse
country: France
facility: CHI Toulouse
city: Milan
country: Italy
facility: Istituto clinico Città Studi
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore
city: Rome
country: Italy
facility: Provincia Religiosa San Pietro Di Roma
city: Birmingham
country: United Kingdom
facility: Sandwell and West Birmingham Hospitals
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Southampton
country: United Kingdom
facility: Southampton
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospital of North Midlands NHS Trust
Study officials:
affiliation: The Cleveland Clinic
name: Khaldoun Trajki, MD
role: PRINCIPAL_INVESTIGATOR
References: