BlueSync Field Evaluation

Bradycardia Clinical Trial

Official title:

BlueSync Field Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518658
• Other study ID #: BlueSync Field Evaluation
• Status: Completed
• Start date: April 2, 2018
• Est. completion date: December 29, 2019

Study information

• Verified date: April 2021
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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™.

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 information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: December 29, 2019
• Est. primary completion date: December 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Bradycardia

Intervention

Other:
• Evaluation Group
Patient receiving exposure to the MyCareLink Heart App during device pairing
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  France,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acute CareLink Transmission Success	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