Study Results
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View full resultsBasic Information
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COMPLETED
257 participants
OBSERVATIONAL
2018-04-02
2019-12-29
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Evaluation Group
Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App
Evaluation Group
Patient receiving exposure to the MyCareLink Heart App during device pairing
Control Group
Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Khaldoun Trajki, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol: Version 1
Document Type: Study Protocol: Version 2
Document Type: Study Protocol: Version 3
Document Type: Statistical Analysis Plan
Other Identifiers
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BlueSync Field Evaluation
Identifier Type: -
Identifier Source: org_study_id
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