Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
287 participants
OBSERVATIONAL
2013-06-30
2014-08-31
Brief Summary
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* To evaluate the Heart Failure Risk Status (HFRS) feature performance.
* To establish the feasibility of remote follow-up in which patient risk triaging is performed by nurse-led review of HFRS feature as supplemental information.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy Defibrillator/Pacemaker
Eligibility Criteria
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Inclusion Criteria
* Implant of a commercially available Medtronic CRTD or ICD device with or without the Optivol Fluid Status Monitoring feature.
* Inclusion in the Medtronic Carelink Network.
* Local consent available for CL network as well as general local consent available for the use of data in observational studies signed and informative sheet delivered.
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Other Identifiers
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PRoMOTE FU
Identifier Type: -
Identifier Source: org_study_id
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