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Can a device alert predict heart failure worsening?

NCT ID NCT04489225

Knowledge-focused Sponsor: Medtronic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how well a feature called TriageHF, built into Medtronic heart devices, can predict when heart failure might get worse. About 2200 people with these devices are being followed in regular doctor visits. The goal is to see if the high-risk alerts correctly identify patients who need urgent care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2020

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population includes all patients implanted with a Medtronic Cobalt™ XT ICD or CRT-D MRI SureScan™ (with Attain StabilityQuad™ MRI SureScan™ Model 4798 Lead (ASQ)), who are enrolled in the Medtronic CareLink (CL) Network and Product Surveillance Registry (PSR).

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * Patient has or is intended to receive or be treated with an eligible ICD or CRT device or Patients may be enrolled pre-implant and up to 30 days post-implant following confirmation of patient eligibility. * Patient is enrolled in the Medtronic CareLink® Network for remote monitoring. Exclusion Criteria: * Patient who is, or is expected to be inaccessible for follow-up * Patient with exclusion criteria required by local law * Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results.

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

Contacts and locations

Locations

  • Associates in Cardiology PA

    Silver Spring, Maryland, 20910-1265, United States

  • Athens Medical Center

    Marousi, Greece

  • Aurora Cardiovascular Services

    Milwaukee, Wisconsin, 53215, United States

  • Azienda Ospedaliera Ospedale Niguarda Ca Granda

    Milan, Italy

  • Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"

    Cosenza, Italy

  • Azienda ospedaleria Santa Maria della Misericordia di Udine

    Udine, Italy

  • Baptist Health

    Jacksonville, Florida, 32207, United States

  • Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital

    Blackpool, United Kingdom

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CHRU La Rochelle

    La Rochelle, France

  • CHU de Brest

    Brest, France

  • CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol

    Caen, France

  • CHU de Dijon - Hospital Le Bocage

    Dijon, France

  • Capio - Clinique du Tonkin

    Villeurbanne, France

  • Cardiology Associates Medical Group

    Ventura, California, 93003-2840, United States

  • Cardiopark Zurich

    Zurich, Switzerland

  • Cardiovascular Consultants Medical Group

    Van Nuys, California, 91405, United States

  • Cardiovascular Institute of Northwest Florida

    Panama City, Florida, 32405, United States

  • Central Manchester University Hospitals NHS - Manchester Royal Infirmary

    Manchester, United Kingdom

  • Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

    Clermont-Ferrand, France

  • Centro Hospitalar Universitário de São João

    Porto, Portugal

  • Ch de La Region D'Annecy

    Metz-Tessy, France, France

  • Chu Nord Saint-Étienne

    Saint-Priest-en-Jarez, France, France

  • Chula Vista Cardiac Center

    Chula Vista, California, 91910, United States

  • Clinique Rhone Durance

    Avignon, France, France

  • Colorado Heart and Vascular, PC

    Lakewood, Colorado, 80228, United States

  • Colorado Springs Cardiology

    Colorado Springs, Colorado, 80907, United States

  • Complejo Hospitalario Universitario de Santiago de Compostela

    Santiago, Spain

  • Complejo Universitario de Salamanca

    Salamanca, Spain

  • Consultants in Cardiology

    Fort Worth, Texas, 76104-2821, United States

  • Deaconess Specialty Physicians

    Evansville, Indiana, 47710-1658, United States

  • Denver Heart

    Denver, Colorado, 80220-3918, United States

  • Générale de Santé - Hôpital Privé Saint Martin

    Caen, France

  • Hartford Hospital

    Hartford, Connecticut, 06102-8000, United States

  • Heart & Vascular Institute of Florida

    Safety Harbor, Florida, 34695-6604, United States

  • Heart Center of North Texas

    Fort Worth, Texas, 76104, United States

  • Heart Rhythm Consultants P.A. (Sarasota Memorial Research)

    Sarasota, Florida, 34233, United States

  • Heart Rhythm Solutions

    Hollywood, Florida, 33021, United States

  • Hospital Clínico Universitario de Valladolid

    Valladolid, Spain

  • Hospital Distrital de Santarém

    Santarém, Portugal

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Clínico San Cecilio

    Granada, Spain

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, Spain

  • Hospital Universitario Virgen de las Nieves

    Granada, Spain

  • Hospital Universitario da Coruña

    A Coruña, Spain

  • Hospital da Senhora da Oliveira - Guimarães

    Guimarães, Portugal

  • Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE

    Lisbon, Portugal

  • Hudson Valley Heart Center

    Poughkeepsie, New York, 12601-3923, United States

  • Huntington Hospital

    Huntington, New York, 11743, United States

  • Hygeia Hospital

    Athens, Greece

  • Hôpitaux Universitaires de Genève

    Geneva, Switzerland

  • Imperial College Healthcare NHS Trust - Hammersmith Hospital

    London, United Kingdom

  • Iowa Heart

    Des Moines, Iowa, 50266, United States

  • Lenox Hill Hospital

    New York, New York, 10075, United States

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool, United Kingdom

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Michigan Heart

    Ypsilanti, Michigan, 48197-8633, United States

  • Missouri Cardiovascular Specialists

    Columbia, Missouri, 65201-8023, United States

  • Monmouth Cardiology Associates

    Eatontown, New Jersey, 07724, United States

  • Nebraska Medicine

    Omaha, Nebraska, 68105, United States

  • New York-Presbyterian Hospital/Weill-Cornell Medical Center

    New York, New York, 10021, United States

  • NewYork-Presbyterian/Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549, United States

  • Norton Heart and Vascular Institute

    Louisville, Kentucky, 40205-3373, United States

  • Nouvelles Cliniques Nantaises

    Nantes, France, France

  • Národný ústav srdcových a cievnych chorôb, a.s. (NÚSCH, a.s.)

    Bratislava, Slovakia

  • Ospedale "Vito Fazzi" Lecce

    Lecce, Italy

  • Policlinico Sant' Orsola - Malpighi

    Bologna, Italy

  • Presbyterian Heart Group

    Albuquerque, New Mexico, 87106-4921, United States

  • Presidio Ospedaliero Centrale - SS. Annunziata

    Taranto, Italy

  • Saint Lukes Health System

    Kansas City, Missouri, 64111-5934, United States

  • Saint Thomas Research Institute

    Nashville, Tennessee, 37205-2018, United States

  • Saint Vincent Heart Clinic Arkansas

    Little Rock, Arkansas, 72205-6202, United States

  • Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General

    Sheffield, United Kingdom

  • South Shore University Hospital

    Bay Shore, New York, 11706, United States

  • Southwest EP

    Chandler, Arizona, 85226, United States

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912, United States

  • St Lukes University Health Network

    Bethlehem, Pennsylvania, 18015, United States

  • Staten Island University Hospital

    Staten Island, New York, 10305, United States

  • Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists

    Akron, Ohio, 44304-1473, United States

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705-1852, United States

  • The Christ Hospital Health Network

    Cincinnati, Ohio, 45219, United States

  • The James Cook University Hospital - South Tees Hospitals NHS

    Middlesbrough, United Kingdom

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160-8500, United States

  • TidalHealth Peninsula Regional, Inc.

    Salisbury, Maryland, 21804, United States

  • University Hospital of Missouri

    Columbia, Missouri, 65212, United States

  • University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

    Birmingham, United Kingdom

  • WakeMed Health & Hospitals

    Raleigh, North Carolina, 27610, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110-1010, United States

  • Yale New Haven Hospital

    New Have, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.