Personalized Therapy Study - HFRS (TriageHF) Post Approval Study

October 16, 2025 updated by: Medtronic

Personalized Therapy Study - Heart Failure Risk Status (TriageHF) Post Approval Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France
        • CHU de Brest
      • Caen, France
        • CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol
      • Caen, France
        • Générale de Santé - Hôpital Privé Saint Martin
      • Clermont-Ferrand, France
        • Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
      • Dijon, France
        • CHU de Dijon - Hospital Le Bocage
      • La Rochelle, France
        • CHRU La Rochelle
      • Villeurbanne, France
        • Capio - Clinique du Tonkin
    • France
      • Avignon, France, France
        • Clinique Rhône Durance
      • Metz-Tessy, France, France
        • CH de la région d'Annecy
      • Nantes, France, France
        • Nouvelles Cliniques Nantaises
      • Saint-Priest-en-Jarez, France, France
        • Chu Nord Saint-Étienne
  • Greece
      • Athens, Greece
        • Hygeia Hospital
      • Marousi, Greece
        • Athens Medical Center
  • Italy
      • Bologna, Italy
        • Policlinico Sant' Orsola - Malpighi
      • Cosenza, Italy
        • Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"
      • Lecce, Italy
        • Ospedale "Vito Fazzi" Lecce
      • Milan, Italy
        • Azienda Ospedaliera Ospedale Niguarda Ca Granda
      • Taranto, Italy
        • Presidio Ospedaliero Centrale - SS. Annunziata
      • Udine, Italy
        • Azienda ospedaleria Santa Maria della Misericordia di Udine
  • Portugal
      • Guimarães, Portugal
        • Hospital da Senhora da Oliveira - Guimarães
      • Lisbon, Portugal
        • Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
      • Porto, Portugal
        • Centro Hospitalar Universitario de Sao Joao
      • Santarém, Portugal
        • Hospital Distrital de Santarém
  • Slovakia
      • Bratislava, Slovakia
        • Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)
  • Spain
      • A Coruña, Spain
        • Hospital Universitario da Coruna
      • Granada, Spain
        • Hospital Universitario Virgen de las Nieves
      • Granada, Spain
        • Hospital Universitario Clínico San Cecilio
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Salamanca, Spain
        • Complejo Universitario de Salamanca
      • Santa Cruz de Tenerife, Spain
        • Hospital Universitario Nuestra Señora de Candelaria
      • Santiago, Spain
        • Complejo Hospitalario Universitario de Santiago de Compostela
      • Valladolid, Spain
        • Hospital Clinico Universitario de Valladolid
  • Switzerland
      • Geneva, Switzerland
        • Hôpitaux Universitaires de Genève
      • Zurich, Switzerland
        • Cardiopark Zurich
  • United Kingdom
      • Birmingham, United Kingdom
        • University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
      • Blackpool, United Kingdom
        • Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital
      • Liverpool, United Kingdom
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
      • London, United Kingdom
        • Imperial College Healthcare Nhs Trust - Hammersmith Hospital
      • Manchester, United Kingdom
        • Central Manchester University Hospitals NHS - Manchester Royal Infirmary
      • Middlesbrough, United Kingdom
        • The James Cook University Hospital - South Tees Hospitals NHS
      • Sheffield, United Kingdom
        • Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85226
        • Southwest EP
    • Arkansas
      • Little Rock, Arkansas, United States, 72205-6202
        • Saint Vincent Heart Clinic Arkansas
    • California
      • Chula Vista, California, United States, 91910
        • Chula Vista Cardiac Center
      • Van Nuys, California, United States, 91405
        • Cardiovascular Consultants Medical Group
      • Ventura, California, United States, 93003-2840
        • Cardiology Associates Medical Group
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Colorado Springs Cardiology
      • Denver, Colorado, United States, 80220-3918
        • Denver Heart
      • Lakewood, Colorado, United States, 80228
        • Colorado Heart and Vascular, PC
    • Connecticut
      • Hartford, Connecticut, United States, 06102-8000
        • Hartford Hospital
      • New Have, Connecticut, United States, 06510
        • Yale New Haven Hospital
    • Florida
      • Hollywood, Florida, United States, 33021
        • Heart Rhythm Solutions
      • Jacksonville, Florida, United States, 32207
        • Baptist Health
      • Panama City, Florida, United States, 32405
        • Cardiovascular Institute of Northwest Florida
      • Safety Harbor, Florida, United States, 34695-6604
        • Heart & Vascular Institute of Florida
      • Sarasota, Florida, United States, 34233
        • Heart Rhythm Consultants P.A. (Sarasota Memorial Research)
    • Indiana
      • Evansville, Indiana, United States, 47710-1658
        • Deaconess Specialty Physicians
    • Iowa
      • Des Moines, Iowa, United States, 50266
        • Iowa Heart
    • Kansas
      • Kansas City, Kansas, United States, 66160-8500
        • The University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40205-3373
        • Norton Heart and Vascular Institute
    • Maryland
      • Salisbury, Maryland, United States, 21804
        • TidalHealth Peninsula Regional, Inc.
      • Silver Spring, Maryland, United States, 20910-1265
        • Associates in Cardiology PA
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Sparrow Clinical Research Institute
      • Ypsilanti, Michigan, United States, 48197-8633
        • Michigan Heart
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Columbia, Missouri, United States, 65201-8023
        • Missouri Cardiovascular Specialists
      • Columbia, Missouri, United States, 65212
        • University Hospital of Missouri
      • Kansas City, Missouri, United States, 64111-5934
        • Saint Lukes Health System
      • St Louis, Missouri, United States, 63110-1010
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Nebraska Medicine
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Monmouth Cardiology Associates
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106-4921
        • Presbyterian Heart Group
    • New York
      • Bay Shore, New York, United States, 11706
        • South Shore University Hospital
      • Huntington, New York, United States, 11743
        • Huntington Hospital
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • Mount Kisco, New York, United States, 10549
        • Northern Westchester Hospital
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10075
        • Lenox Hill Hospital
      • New York, New York, United States, 10032
        • NewYork-Presbyterian/Columbia University Irving Medical Center
      • New York, New York, United States, 10021
        • New York-Presbyterian Hospital/Weill-Cornell Medical Center
      • Poughkeepsie, New York, United States, 12601-3923
        • Hudson Valley Heart Center
      • Staten Island, New York, United States, 10305
        • Staten Island University Hospital
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • WakeMed Health & Hospitals
    • Ohio
      • Akron, Ohio, United States, 44304-1473
        • Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital Health Network
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St Lukes University Health Network
    • Tennessee
      • Nashville, Tennessee, United States, 37205-2018
        • Saint Thomas Research Institute
    • Texas
      • Austin, Texas, United States, 78705-1852
        • Texas Cardiac Arrhythmia Research Foundation
      • Fort Worth, Texas, United States, 76104
        • Heart Center of North Texas
      • Fort Worth, Texas, United States, 76104-2821
        • Consultants in Cardiology
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Cardiovascular Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
This single arm observational study 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). Patients will be followed per the standard of care practices of their care provider. All patients must provide a signed informed consent.
Other: Observational
Observational only without any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure
Time Frame: Up to 5 years
To estimate the positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of HF hospitalization or HF related deaths
Time Frame: Up to 5 years
Summarize the number of HF hospitalization or HF related deaths that were not preceded by a High-Risk Status.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

December 6, 2024

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

July 27, 2020

First Posted (Actual)

July 28, 2020

Study Record Updates

Last Update Posted (Estimated)

October 20, 2025

Last Update Submitted That Met QC Criteria

October 16, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFRS PAS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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