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NCT03518658

BlueSync Field Evaluation

Completed Results posted Last updated 6 May 2021
What this trial tests

trial testing Evaluation Group in Bradycardia in 257 participants. Completed in 29 December 2019.

Timeline
2 April 2018
Primary endpoint
29 December 2019
29 December 2019

Quick facts

Lead sponsorMedtronic Cardiac Rhythm and Heart Failure
StatusCompleted
Study typeOBSERVATIONAL
Enrollment257
Start date2 April 2018
Primary completion29 December 2019
Estimated completion29 December 2019
Sites20 locations across France, United Kingdom, United States, Italy

Drugs / interventions tested

Conditions studied

Sponsor

Medtronic Cardiac Rhythm and Heart Failure — full company profile →

Who can join

18 and older, any sex, with Bradycardia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Chronic CareLink Transmission Success Primary · 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

GroupValue95% CI
Evaluation Group94.691.8 – 96.6
Control Group (Historical)60.059.7 – 60.2
Matched Control Group (Historical)56.353.7 – 58.9
Acute CareLink Transmission Success Secondary · 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

GroupValue95% CI
Evaluation Group95.192 – 97

Sponsor's own description

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™.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Performance of first pacemaker to use smart device app for remote monitoring.
    Tarakji KG, Zaidi AM, Zweibel SL, Varma N, et al · · 2021 · cited 21× · PMID 34667961 · DOI 10.1016/j.hroo.2021.07.008
  2. The Use of App-based Follow-up of Cardiac Implantable Electronic Devices.
    Roberts PR, ElRefai MH. · · 2020 · cited 8× · PMID 32377382 · DOI 10.15420/cfr.2019.13

Verify or expand the search:

Other trials of Evaluation Group

Trials testing the same drug.

Other recruiting trials for Bradycardia

Currently open trials in the same condition.

Other Medtronic Cardiac Rhythm and Heart Failure trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03518658.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing