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NCT04489225Active, not recruiting

Personalized Therapy Study - HFRS (TriageHF) Post Approval Study

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

Source: ClinicalTrials.gov · Last updated 20 Oct 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
2200 (estimated)
First submitted
23 Jul 2020
Start date
1 Aug 2020
Primary completion date
6 Dec 2024
Lead sponsor
Medtronic
NCT number
NCT04489225

What you commit to

  • Study type: Observational
  • Planned participants: 2200
  • From 1 Aug 2020 to the primary completion date, 6 Dec 2024
  • 92 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results.

Other

  • Patient who is, or is expected to be inaccessible for follow-up
  • Patient with exclusion criteria required by local law

Who the study is looking for

  • 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.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (92)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hôpitaux universitaires de Genève
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GenevaSwitzerlandUnknown status
Cardiopark Zurich
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ZurichSwitzerlandUnknown status
Hospital Universitario da Coruña
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A CoruñaSpainUnknown status
Hospital Universitario Clínico San Cecilio
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GranadaSpainUnknown status
Hospital Universitario Virgen de las Nieves
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GranadaSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Complejo Universitario de Salamanca
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SalamancaSpainUnknown status
Hospital Universitario Nuestra Señora de Candelaria
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Santa Cruz de TenerifeSpainUnknown status
Complejo Hospitalario Universitario de Santiago de Compostela
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SantiagoSpainUnknown status
Hospital Clínico Universitario de Valladolid
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ValladolidSpainUnknown status
Clinique Rhône Durance
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AvignonFranceUnknown status
CHU de Brest
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BrestFranceUnknown status
Générale de Santé - Hôpital Privé Saint Martin
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CaenFranceUnknown status
CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol
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CaenFranceUnknown status
Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied
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Clermont-FerrandFranceUnknown status
CHU de Dijon - Hospital Le Bocage
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DijonFranceUnknown status
CHRU La Rochelle
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La RochelleFranceUnknown status
CH de la Region d'Annecy
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Metz-TessyFranceUnknown status
Nouvelles Cliniques Nantaises
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NantesFranceUnknown status
Chu Nord Saint-Étienne
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Saint-Priest-en-JarezFranceUnknown status
Capio - Clinique du Tonkin
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VilleurbanneFranceUnknown status
University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
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BirminghamUnited KingdomUnknown status
Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital
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BlackpoolUnited KingdomUnknown status
Liverpool Heart and Chest Hospital NHS Foundation Trust
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LiverpoolUnited KingdomUnknown status
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
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LondonUnited KingdomUnknown status
Central Manchester University Hospitals NHS - Manchester Royal Infirmary
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ManchesterUnited KingdomUnknown status
The James Cook University Hospital - South Tees Hospitals NHS
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MiddlesbroughUnited KingdomUnknown status
Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General
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SheffieldUnited KingdomUnknown status
HYGEIA Hospital
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AthensGreeceUnknown status
Athens Medical Center
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MarousiGreeceUnknown status
Policlinico Sant'Orsola-Malpighi
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BolognaItalyUnknown status
Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"
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CosenzaItalyUnknown status
Ospedale Vito Fazzi Lecce
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LecceItalyUnknown status
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
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MilanItalyUnknown status
Presidio Ospedaliero Centrale - SS. Annunziata
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TarantoItalyUnknown status
Azienda ospedaleria Santa Maria della Misericordia di Udine
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UdineItalyUnknown status
Hospital Da Senhora Da Oliveira Guimarăes
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GuimarãesPortugalUnknown status
Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
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LisbonPortugalUnknown status
Centro Hospitalar Universitário de São João
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PortoPortugalUnknown status
Hospital Distrital de Santarém
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SantarémPortugalUnknown status
Národný ústav srdcových a cievnych chorôb, a.s. (NÚSCH, a.s.)
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BratislavaSlovakiaUnknown status
Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists
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AkronUnited StatesUnknown status
Presbyterian Heart Group
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AlbuquerqueUnited StatesUnknown status
Texas Cardiac Arrhythmia Research Foundation
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AustinUnited StatesUnknown status
South Shore University Hospital
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Bay ShoreUnited StatesUnknown status
St. Lukes University Health Network
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BethlehemUnited StatesUnknown status
Brigham and Women's Hospital
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BostonUnited StatesUnknown status
Southwest EP
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ChandlerUnited StatesUnknown status
Chula Vista Cardiac Center
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Chula VistaUnited StatesUnknown status
The Christ Hospital Health Network
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CincinnatiUnited StatesUnknown status
Colorado Springs Cardiology
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Colorado SpringsUnited StatesUnknown status
Missouri Cardiovascular Specialists
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ColumbiaUnited StatesUnknown status
University Hospital of Missouri
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ColumbiaUnited StatesUnknown status
Denver Heart
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DenverUnited StatesUnknown status
Iowa Heart
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Des MoinesUnited StatesUnknown status
Monmouth Cardiology Associates
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EatontownUnited StatesUnknown status
Deaconess Specialty Physicians
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EvansvilleUnited StatesUnknown status
Consultants in Cardiology
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Fort WorthUnited StatesUnknown status
Heart Center of North Texas
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Fort WorthUnited StatesUnknown status
Hartford Hospital
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HartfordUnited StatesUnknown status
Heart Rhythm Solutions
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HollywoodUnited StatesUnknown status
Huntington Hospital
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HuntingtonUnited StatesUnknown status
Baptist Health
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JacksonvilleUnited StatesUnknown status
Saint Lukes Health System
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Kansas CityUnited StatesUnknown status
The University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
Colorado Heart and Vascular PC
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LakewoodUnited StatesUnknown status
Sparrow Clinical Research Institute
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LansingUnited StatesUnknown status
Saint Vincent Heart Clinic Arkansas
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Little RockUnited StatesUnknown status
Norton Heart and Vascular Institute
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LouisvilleUnited StatesUnknown status
North Shore University Hospital
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ManhassetUnited StatesUnknown status
Aurora Cardiovascular Services
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MilwaukeeUnited StatesUnknown status
Northern Westchester Hospital
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Mount KiscoUnited StatesUnknown status
Saint Thomas Research Institute
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NashvilleUnited StatesUnknown status
Yale New Haven Hospital
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New HaveUnited StatesUnknown status
Long Island Jewish Medical Center
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New Hyde ParkUnited StatesUnknown status
Lenox Hill Hospital
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New YorkUnited StatesUnknown status
NewYork-Presbyterian / Columbia University Irving Medical Center
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New YorkUnited StatesUnknown status
New York-Presbyterian Hospital/Weill Cornell Medical Center
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New YorkUnited StatesUnknown status
Nebraska Medicine
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OmahaUnited StatesUnknown status
Cardiovascular Institute of Northwest Florida
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Panama CityUnited StatesUnknown status
Hudson Valley Heart Center
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PoughkeepsieUnited StatesUnknown status
WakeMed Health & Hospitals
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RaleighUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
Heart & Vascular Institute of Florida
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Safety HarborUnited StatesUnknown status
TidalHealth Peninsula Regional, Inc.
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SalisburyUnited StatesUnknown status
Heart Rhythm Consultants P.A. (Sarasota Memorial Research)
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SarasotaUnited StatesUnknown status
Associates in Cardiology PA
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Silver SpringUnited StatesUnknown status
Staten Island University Hospital
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Staten IslandUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
Cardiovascular Consultants Medical Group
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Van NuysUnited StatesUnknown status
Cardiology Associates Medical Group
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VenturaUnited StatesUnknown status
Michigan Heart
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YpsilantiUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.