CompletedNot Applicable

Integrated Diagnostic for Heart Failure

Canada100 participantsStarted 2013-08

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Heart Failure Risk Status Performance Characterization

Timeframe: from baseline until a subject completes 8 months of follow up

Trial details

NCT IDNCT01798797

SponsorMedtronic

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-07

View on ClinicalTrials.gov More Heart Failure trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.