Integrated Diagnostic for Heart Failure

Heart Failure Clinical Trial

Official title:

Integrated Diagnostic for Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798797
• Other study ID #: TRIAGE-HF
• Status: Completed
• Start date: August 2013
• Est. completion date: July 2015

Study information

• Verified date: September 2018
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	St. Boniface Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart Failure Risk Status and medical management	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