BlueSync Field Evaluation

Completed

Conditions studied: Bradycardia

In brief

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™.

Key facts

Study ID

NCT03518658

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

257

Starts

2018-04-02

Expected to finish

2019-12-29

Last updated by the study team

2021-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patient unwilling to complete required surveys during 12-month evaluation period

Where it is running

• 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
• University of Kansas Medical Center — Kansas City, Kansas, United States
• CentraCare — Saint Cloud, Minnesota, United States
• The Valley Hospital — Ridgewood, New Jersey, United States
• Cone Health — Greensboro, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Mount Carmel — Columbus, Ohio, United States
• East Tennessee Consultants — Knoxville, Tennessee, United States
• CHU Bordeaux — Bordeaux, France
• CHI Toulouse — Toulouse, France
• Istituto clinico Città Studi — Milan, Italy
• Ospedale Sacro Cuore — Negrar, Italy
• Provincia Religiosa San Pietro Di Roma — Rome, Italy
• 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 Kingdom

Full record on ClinicalTrials.gov

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