Active not recruitingOBSERVATIONAL

Personalized Therapy Study - HFRS (TriageHF) Post Approval Study

This study is checking how a feature called TriageHF, found in Medtronic heart devices, works for people with heart failure. It's an observational study, meaning researchers will simply watch and record what happens in real-life medical care, rather than testing a specific treatment. They want to see how this feature performs after it's been made available for general use. The study gathers information from patients who already have certain Medtronic heart devices and use Medtronic's remote monitoring system. The aim is to understand how the TriageHF feature helps doctors and patients manage heart failure in everyday situations.

At a glance

Status

Active not recruiting

Sponsor

Medtronic

Enrolment target

2,200

Start

01 Aug 2020

Estimated completion

31 Jan 2028

Heart Failure

What is this study about?

Heart failure means your heart isn't pumping blood around your body as well as it should. It's a serious condition, but advances in technology, like special heart devices, can help manage it. This particular study is about a feature called TriageHF, which is part of certain Medtronic heart devices. These devices are designed to help your heart work better.

After a new medical feature or device is approved for use, it's really important to see how it works in the real world, outside of very strict testing conditions. That's exactly what this study is doing. It's not trying out a new treatment; instead, it's carefully observing how the TriageHF feature is used by doctors and how it helps patients in their day-to-day medical care. Think of it like watching how a new car model performs on regular roads after it's been released to the public.

The main goal is to understand how useful and effective the TriageHF feature is in managing heart failure when it's used in normal clinical practice. This information will help doctors and Medtronic better understand how to use this technology to support patients living with heart failure.

Key takeaways

This study observes how a heart device feature (TriageHF) works in real life.
It's for people with certain Medtronic heart devices and using remote monitoring.
You will receive your usual medical care; no new treatments are given.
There are no extra appointments required for this study.
Your participation helps improve understanding of heart device technology for future patients.

Who may be eligible?

To join this study, you would need to agree to be part of it, either yourself or through someone legally able to make decisions for you. This agreement must follow local rules where you live and receive care.

You should either already have, or be planning to get, a specific type of Medtronic heart device – either an ICD (implantable cardioverter-defibrillator) or a CRT (cardiac resynchronization therapy) device. If you're getting one, you can join just before your device is put in, or up to 30 days afterwards. You also need to be using Medtronic's CareLink® Network, which is a system for remote monitoring of your device.

There are a few reasons why you might not be able to join. For example, if it's thought you might not be able to attend follow-up appointments, or if local laws prevent your participation. Also, if you are already in another research study that might affect the results of this one, you wouldn't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you agreed to take part, or has someone legally able to make decisions for you?
Do you have, or are you planning to get, a Medtronic Cobalt™ XT CRT or ICD device?
Are you enrolled in the Medtronic CareLink® Network for remote monitoring?
Are you available for your regular follow-up appointments with your care team?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it's important to understand that it's an "observational" study. This means you won't be given any new or experimental treatments. Instead, your doctors will continue to provide you with your usual care, following their standard practices for managing your heart condition and your Medtronic device. The study team will simply collect information from your existing medical records and from your Medtronic CareLink® remote monitoring system.

There are no extra visits or appointments specifically for the study. You will continue with your regular check-ups and follow-up care as advised by your own doctors. The study will track your health information over time as part of your standard medical care. The total duration of your participation would be for as long as your doctor observes you as part of their routine care.

Potential risks and benefits

Because this is an observational study and you will continue to receive your usual medical care, there are no additional physical risks directly linked to being in the study itself. The main potential benefit is that the information gathered from your experience, alongside many other patients, will help researchers and doctors better understand how the TriageHF feature in Medtronic heart devices works in real-life situations. This can help improve care for future patients with heart failure. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (92)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Southwest EP
Verified postcode
Chandler, United States
Saint Vincent Heart Clinic Arkansas
Verified postcode
Little Rock, United States
Chula Vista Cardiac Center
Verified postcode
Chula Vista, United States
Cardiovascular Consultants Medical Group
Verified postcode
Van Nuys, United States
Cardiology Associates Medical Group
Verified postcode
Ventura, United States
Colorado Springs Cardiology
Verified postcode
Colorado Springs, United States
Denver Heart
Verified postcode
Denver, United States
Colorado Heart and Vascular, PC
Verified postcode
Lakewood, United States
Hartford Hospital
Verified postcode
Hartford, United States
Yale New Haven Hospital
Unverified
New Have, United States
Heart Rhythm Solutions
Verified postcode
Hollywood, United States
Baptist Health
Verified postcode
Jacksonville, United States

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood as effectively as it should. It can lead to symptoms like breathlessness and tiredness.

What is the TriageHF feature?

It's a special feature in some Medtronic heart devices designed to help doctors monitor and manage heart failure more effectively.

Will I get a new treatment in this study?

No, this is an observational study. You will continue to receive your usual care from your doctor, with no new treatments specifically for the study.

Will I have extra appointments?

No, you'll only attend your regular, scheduled appointments with your own care team, as you normally would.

Can I leave the study at any time?

Yes, your participation is voluntary, and you can choose to withdraw from the study at any point without it affecting your medical care.