Integrated Diagnostic for Heart Failure

Medtronic

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT01798797

TRIAGE-HF

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

no treatment

Description:

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