Integrated Diagnostic for Heart Failure

September 21, 2018 updated by: Medtronic
A prospective post-market study to evaluate the performance and clinic usability of heart failure risk status (HFRS) feature on CareLink.

Study Overview

Status

Completed

Conditions

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) 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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface Hospital
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with heart failure who have been implanted with an ICD or a CRT-D wirless device for at least 3 months

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
no treatment
non-randomized, all subjects who have been implanted with an ICD or CRT-D for at least 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from baseline until a subject completes 8 months of follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from baseline for each subject until they complete 8 months of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Investigators

  • Principal Investigator: Sean Virani, MD, Vancouver General Hospital, Vancouver, British Columbia, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

February 14, 2013

First Submitted That Met QC Criteria

February 22, 2013

First Posted (Estimate)

February 26, 2013

Study Record Updates

Last Update Posted (Actual)

September 25, 2018

Last Update Submitted That Met QC Criteria

September 21, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIAGE-HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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