Integrated Diagnostic for Heart Failure

Completed

• Conditions: Heart Failure

• Registration Number: NCT01798797
• Lead Sponsor: Medtronic

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) 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 Timeline

• Study First Submitted: 2013-02-14
• Study First Submitted QC: 2013-02-22
• Study First Posted: 2013-02-26
• Study Start: 2013-08
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-21
• Last Update Posted: 2018-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart Failure Risk Status Performance Characterization	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

Name	Time	Method
Heart Failure Risk Status and medical management	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

Trial Locations

Locations (3)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

St. Boniface Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Southlake Regional Health Centre; 🇨🇦 Newmarket, Ontario, Canada