Integrated Diagnostic for Heart Failure

NCT ID: NCT01798797

Last Updated: 2018-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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no treatment

non-randomized, all subjects who have been implanted with an ICD or CRT-D for at least 3 months

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sean Virani, MD

Role: PRINCIPAL_INVESTIGATOR

Vancouver General Hospital, Vancouver, British Columbia, Canada

Locations

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Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Site Status

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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TRIAGE-HF

Identifier Type: -

Identifier Source: org_study_id

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