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Integrated Diagnostic for Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798797
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic

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

Condition or disease
Heart Failure

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Integrated Diagnostic for Heart Failure
Actual Study Start Date : August 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798797


Locations
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Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
Sponsors and Collaborators
Medtronic
Investigators
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Principal Investigator: Sean Virani, MD Vancouver General Hospital, Vancouver, British Columbia, Canada
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Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT01798797    
Other Study ID Numbers: TRIAGE-HF
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Medtronic:
Heart Failure
HFRS
OptiVol
ICD
CRT-D
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases