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OpenTrials
Completed

NCT Number: NCT01798797

Integrated Diagnostic for Heart Failure

A prospective post-market study to evaluate the performance and clinic usability of heart failure risk status (HFRS) feature on CareLink.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vancouver General Hospital, Vancouver, British Columbia, Canada

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About this study

Patients with systolic heart failure (HF) implanted with Medtronic wireless implantable cardiac defibrillator (ICD) or cardiac resynchronization therapy device with defibrillation capabilities (CRT-D) devices will be enrolled in the study. The purpose of the study is to evaluate the usability of CareLink HFRS to manage a patient's heart failure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Heart Failure Risk Status Performance Characterization

    Time frame: from baseline until a subject completes 8 months of follow up

    The clinical signs and symptoms of worsening HF that are associated with an Heart Failure Risk Status triggered by an OptiVol alert

Secondary outcomes

  1. Heart Failure Risk Status and medical management

    Time frame: from baseline for each subject until they complete 8 months of follow up

    The correlation between HFRS burden and clinician's assessment of a subject risk and the subject's medical management

Sponsors and collaborators

Lead sponsor

Medtronic

Industry

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 26, 2013
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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