Personalized Therapy Study - HFRS (TriageHF) Post Approval Study

Last updated: March 31, 2025
Sponsor: Medtronic
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Hyponatremia

Chest Pain

Treatment

Observational

Clinical Study ID

NCT04489225
HFRS PAS
  • All Genders

Study Summary

Medtronic is sponsoring the HFRS PAS to evaluate the HFRS feature (TriageHF) when used in routine clinical practice following commercial release. The HFRS PAS is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient or legally authorized representative provides written authorization and/orconsent per institution and geographical requirements

  • Patient has or is intended to receive or be treated with an eligible ICD or CRTdevice or Patients may be enrolled pre-implant and up to 30 days post-implantfollowing confirmation of patient eligibility.

  • Patient is enrolled in the Medtronic CareLink® Network for remote monitoring.

Exclusion

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/ordevice study that may confound results.

Study Design

Total Participants: 2200
Treatment Group(s): 1
Primary Treatment: Observational
Phase:
Study Start date:
August 01, 2020
Estimated Completion Date:
January 31, 2027

Study Description

The HFRS PAS is a global, prospective, observational, multi-site study. Patients implanted with a Medtronic Cobalt™ XT CRT (with Attain StabilityQuad™ MRI SureScan™ Model 4798 Lead (ASQ)) or ICD device who are enrolled in the Medtronic CareLink (CL) Network and the PSR will be followed per the standard of care practices of their care provider.

Connect with a study center

  • Clinique Rhone Durance

    Avignon,
    France

    Site Not Available

  • Centre Hospitalier de la Côte Basque

    Bayonne,
    France

    Site Not Available

  • CHU de Brest

    Brest,
    France

    Site Not Available

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

    Caen,
    France

    Site Not Available

  • Générale de Santé - Hôpital Privé Saint Martin

    Caen,
    France

    Site Not Available

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

    Clermont Ferrand,
    France

    Site Not Available

  • CHU de Clermont Ferrand

    Clermont-Ferrand,
    France

    Site Not Available

  • CHU de Dijon - Hospital Le Bocage

    Dijon,
    France

    Site Not Available

  • CHRU La Rochelle

    La Rochelle,
    France

    Site Not Available

  • Hopital prive Clairval - Ramsay Sante

    Marseille,
    France

    Site Not Available

  • Ch de La Region D'Annecy

    Metz-Tessy,
    France

    Site Not Available

  • Nouvelles Cliniques Nantaises

    Nantes,
    France

    Site Not Available

  • Chu Nord Saint-Étienne

    Saint-Priest-en-Jarez,
    France

    Site Not Available

  • Capio - Clinique du Tonkin

    Villeurbanne,
    France

    Site Not Available

  • Hygeia Hospital

    Athens,
    Greece

    Site Not Available

  • Athens Medical Center

    Maroúsi,
    Greece

    Site Not Available

  • Azienda Ospedaliera - Universitaria Consorziale Policlinico di Bari

    Bari,
    Italy

    Site Not Available

  • Policlinico Sant' Orsola - Malpighi

    Bologna,
    Italy

    Site Not Available

  • Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"

    Cosenza,
    Italy

    Site Not Available

  • Ospedale "Vito Fazzi" Lecce

    Lecce,
    Italy

    Site Not Available

  • Azienda Ospedaliera Ospedale Niguarda Ca Granda

    Milano,
    Italy

    Site Not Available

  • Presidio Ospedaliero Centrale - SS. Annunziata

    Taranto,
    Italy

    Site Not Available

  • Azienda ospedaleria Santa Maria della Misericordia di Udine

    Udine,
    Italy

    Site Not Available

  • Hospital da Senhora da Oliveira - Guimarães

    Guimarães,
    Portugal

    Site Not Available

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

    Lisbon,
    Portugal

    Site Not Available

  • Centro Hospitalar Universitário de São João

    Porto,
    Portugal

    Site Not Available

  • Hospital Distrital de Santarém

    Santarém,
    Portugal

    Site Not Available

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

    Bratislava,
    Slovakia

    Site Not Available

  • Hospital Universitario da Coruña

    Coruña,
    Spain

    Site Not Available

  • Hospital Universitario Clínico San Cecilio

    Granada,
    Spain

    Site Not Available

  • Hospital Universitario Virgen de las Nieves

    Granada,
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid,
    Spain

    Site Not Available

  • Complejo Universitario de Salamanca

    Salamanca,
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Santiago de Compostela

    Santiago,
    Spain

    Site Not Available

  • Hospital Universitario Nuestra Señora de Candelaria

    Tenerife,
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valladolid

    Valladolid,
    Spain

    Site Not Available

  • Kantonsspital Aarau

    Aarau,
    Switzerland

    Site Not Available

  • Hôpitaux Universitaires de Genève

    Geneve,
    Switzerland

    Site Not Available

  • Cardiopark Zurich

    Zürich,
    Switzerland

    Site Not Available

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

    Birmingham,
    United Kingdom

    Site Not Available

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

    Blackpool,
    United Kingdom

    Site Not Available

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool,
    United Kingdom

    Site Not Available

  • Imperial College Healthcare NHS Trust - Hammersmith Hospital

    London,
    United Kingdom

    Site Not Available

  • Central Manchester University Hospitals NHS - Manchester Royal Infirmary

    Manchester,
    United Kingdom

    Site Not Available

  • The James Cook University Hospital - South Tees Hospitals NHS

    Middlesbrough,
    United Kingdom

    Site Not Available

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

    Sheffield,
    United Kingdom

    Site Not Available

  • Alaska Heart

    Anchorage, Alaska 99508-4673
    United States

    Site Not Available

  • Southwest EP

    Chandler, Arizona 85226
    United States

    Site Not Available

  • Cardiology Associates of Northeast Arkansas

    Jonesboro, Arkansas 72410-4163
    United States

    Site Not Available

  • Saint Vincent Heart Clinic Arkansas

    Little Rock, Arkansas 72205-6202
    United States

    Site Not Available

  • Chula Vista Cardiac Center

    Chula Vista, California 91910
    United States

    Site Not Available

  • San Diego Arrhythmia Associates

    San Diego, California 92103-2120
    United States

    Site Not Available

  • COR Healthcare

    Torrance, California 90505
    United States

    Site Not Available

  • Cardiovascular Consultants Medical Group

    Van Nuys, California 91405
    United States

    Site Not Available

  • Cardiology Associates Medical Group

    Ventura, California 93003-2840
    United States

    Site Not Available

  • Colorado Springs Cardiology

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Denver Heart

    Denver, Colorado 80220-3918
    United States

    Site Not Available

  • Colorado Heart and Vascular, PC

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Hartford Hospital

    Hartford, Connecticut 06102-8000
    United States

    Site Not Available

  • Yale New Haven Hospital

    New Have, Connecticut 06510
    United States

    Site Not Available

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Bradenton Cardiology

    Bradenton, Florida 34205-8805
    United States

    Site Not Available

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida 33756-3356
    United States

    Site Not Available

  • Heart Rhythm Solutions

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Baptist Health

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Cardiovascular Institute of Northwest Florida

    Panama City, Florida 32405
    United States

    Site Not Available

  • Heart & Vascular Institute of Florida

    Safety Harbor, Florida 34695-6604
    United States

    Site Not Available

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

    Sarasota, Florida 34233
    United States

    Site Not Available

  • Phoebe Putney Memorial Hospital

    Albany, Georgia 31701
    United States

    Site Not Available

  • Deaconess Specialty Physicians

    Evansville, Indiana 47710-1658
    United States

    Site Not Available

  • Iowa Heart

    Des Moines, Iowa 50266
    United States

    Site Not Available

  • The University of Kansas Medical Center

    Kansas City, Kansas 66160-8500
    United States

    Site Not Available

  • Saint Elizabeth Healthcare

    Edgewood, Kentucky 41017-3439
    United States

    Site Not Available

  • Norton Heart Specialists

    Louisville, Kentucky 40205-3373
    United States

    Site Not Available

  • Norton Heart and Vascular Institute

    Louisville, Kentucky 40205-3373
    United States

    Site Not Available

  • Our Lady of the Lake Office of Research

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • MedStar Health Research Institute

    Baltimore, Maryland 21237-3958
    United States

    Site Not Available

  • TidalHealth Peninsula Regional, Inc.

    Salisbury, Maryland 21804
    United States

    Site Not Available

  • Associates in Cardiology PA

    Silver Spring, Maryland 20910-1265
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114-2621
    United States

    Site Not Available

  • Sparrow Clinical Research Institute

    Lansing, Michigan 48912
    United States

    Site Not Available

  • UP Health System - Marquette

    Marquette, Michigan 49855-2705
    United States

    Site Not Available

  • Michigan Heart

    Ypsilanti, Michigan 48197-8633
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota 55407-1157
    United States

    Site Not Available

  • North Memorial Heart and Vascular Institute

    Robbinsdale, Minnesota 55422
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Missouri Cardiovascular Specialists

    Columbia, Missouri 65201-8023
    United States

    Site Not Available

  • University Hospital of Missouri

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Saint Lukes Health System

    Kansas City, Missouri 64111-5934
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110-1010
    United States

    Site Not Available

  • Nebraska Medicine

    Omaha, Nebraska 68105
    United States

    Site Not Available

  • Monmouth Cardiology Associates

    Eatontown, New Jersey 07724
    United States

    Site Not Available

  • Presbyterian Heart Group

    Albuquerque, New Mexico 87106-4921
    United States

    Site Not Available

  • South Shore University Hospital

    Bay Shore, New York 11706
    United States

    Site Not Available

  • Huntington Hospital

    Huntington, New York 11743
    United States

    Site Not Available

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

  • Northern Westchester Hospital

    Mount Kisco, New York 10549
    United States

    Site Not Available

  • Northwell Health

    Multiple Locations, New York 11030
    United States

    Site Not Available

  • Long Island Jewish Medical Center

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • Lenox Hill Hospital

    New York, New York 10075
    United States

    Site Not Available

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

    New York, New York 10021
    United States

    Site Not Available

  • NewYork-Presbyterian/Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Lenox Hill Hospital

    New York City, New York 10075
    United States

    Site Not Available

  • Hudson Valley Heart Center

    Poughkeepsie, New York 12601-3923
    United States

    Site Not Available

  • Staten Island University Hospital

    Staten Island, New York 10305
    United States

    Site Not Available

  • Duke University Medical Center (DUMC)

    Durham, North Carolina 27705
    United States

    Site Not Available

  • WakeMed Health & Hospitals

    Raleigh, North Carolina 27610
    United States

    Site Not Available

  • Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists

    Akron, Ohio 44304-1473
    United States

    Site Not Available

  • The Christ Hospital Health Network

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45267-0542
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195-0001
    United States

    Site Not Available

  • St Lukes University Health Network

    Bethlehem, Pennsylvania 18015
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • UPMC Heart and Vascular Institute at UPMC Hamot

    Erie, Pennsylvania 16507-1579
    United States

    Site Not Available

  • Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania 18711
    United States

    Site Not Available

  • Saint Thomas Research Institute

    Nashville, Tennessee 37205-2018
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232-8802
    United States

    Site Not Available

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas 78705-1852
    United States

    Site Not Available

  • Consultants in Cardiology

    Fort Worth, Texas 76104-2821
    United States

    Site Not Available

  • Heart Center of North Texas

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • EP Heart

    The Woodlands, Texas 77384-4103
    United States

    Site Not Available

  • The University of Vermont Medical Center

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Kootenai Heart Clinics Northwest

    Spokane, Washington 99204-2352
    United States

    Site Not Available

  • Aurora Cardiovascular Services

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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