Integrated Diagnostic for Heart Failure (NCT01798797) | Clinical Trial Compass
CompletedNot Applicable
Integrated Diagnostic for Heart Failure
Canada100 participantsStarted 2013-08
Plain-language summary
A prospective post-market study to evaluate the performance and clinic usability of heart failure risk status (HFRS) feature on CareLink.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patient is 18 years of age or older
* Patient ( or patient's legally authorized representative) is willing and able to provide written informed consent
* Patient is willing and able to comply with the required study follow up visits
* Patient is implanted with a Medtronic wireless ICD or CRT-D device capable of OptiVol fluid monitoring feature
* Patient is on Medtronic CareLink network or is willing to be enrolled on the CareLink network
* Patient is being managed, or has been managed, by a HF clinician
* Patient has signed an informed consent for CareLink Network Services
* Patient is implanted with device for at least three months
* Patient is willing and able to transmit data using the CareLink home monitor (2490C).
Exclusion Criteria:
* Patient is participating in another study that may interfere with TRIAGE-HF protocol required procedures
* Patient with an implantable cardiac device that is indicated to reach ERI in less than 12 months
What they're measuring
1
Heart Failure Risk Status Performance Characterization
Timeframe: from baseline until a subject completes 8 months of follow up