Integrated Diagnostic for Heart Failure

NCT01798797 | Completed

• 1 other identifier: TRIAGE-HF
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Heart Failure

Keywords

Heart Failure; HFRS; OptiVol; ICD; CRT-D

Outcome Measures

Primary Outcomes (1)

• Heart Failure Risk Status Performance Characterization

  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 Outcomes (1)

• Heart Failure Risk Status and medical management

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

Study Arms (1)

no treatment

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic: lead

Study Sites (3)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

MeSH Terms

Conditions

Heart Failure; Hemorrhagic Fever with Renal Syndrome

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Hantavirus Infections; Bunyaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Hemorrhagic Fevers, Viral

Study Officials

• Sean Virani, MD

  Vancouver General Hospital, Vancouver, British Columbia, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 26, 2013
• Study Start: August 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)