N/A
N=128,864
BlueSync Field Evaluation
Bradycardia
Bottom Line
View on ClinicalTrials.gov: NCT03518658 ↗Enrolled (actual)
128,864
Serious AEs
—
Results posted
May 2021
Primary outcome: Primary: Chronic CareLink Transmission Success — 94.6; 60.0; 56.3 Percentage of completed transmissions — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Evaluation Group (Other); Control Group (Historical) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chronic CareLink Transmission Success |
94.6; 60.0; 56.3 | <0.001 sig |
| SECONDARY Acute CareLink Transmission Success |
95.1 | — |
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™.
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
Data sourced from ClinicalTrials.gov (NCT03518658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.