Status:
COMPLETED
Integrated Diagnostic for Heart Failure
Lead Sponsor:
Medtronic
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
A prospective post-market study to evaluate the performance and clinic usability of heart failure risk status (HFRS) feature on CareLink.
Detailed Description
Patients with systolic heart failure (HF) implanted with Medtronic wireless implantable cardiac defibrillator (ICD) or cardiac resynchronization therapy device with defibrillation capabilities (CRT-D)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01798797
Start Date
August 1 2013
End Date
July 1 2015
Last Update
September 25 2018
Active Locations (3)
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1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
2
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
3
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9