Personalized Therapy Study - HFRS (TriageHF) Post Approval Study
1 other identifier
observational
2,200
9 countries
92
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
Longer than P75 for all trials
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2020
CompletedFirst Posted
Study publicly available on registry
July 28, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
ExpectedOctober 20, 2025
October 1, 2025
4.4 years
July 23, 2020
October 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure
To estimate the positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure
Up to 5 years
Secondary Outcomes (1)
Number of HF hospitalization or HF related deaths
Up to 5 years
Study Arms (1)
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.
Interventions
Eligibility Criteria
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).
You may qualify if:
- 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.
You may not qualify if:
- Patient who is, or is expected to be inaccessible for follow-up
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtroniclead
Study Sites (92)
Southwest EP
Chandler, Arizona, 85226, United States
Saint Vincent Heart Clinic Arkansas
Little Rock, Arkansas, 72205-6202, United States
Chula Vista Cardiac Center
Chula Vista, California, 91910, United States
Cardiovascular Consultants Medical Group
Van Nuys, California, 91405, United States
Cardiology Associates Medical Group
Ventura, California, 93003-2840, United States
Colorado Springs Cardiology
Colorado Springs, Colorado, 80907, United States
Denver Heart
Denver, Colorado, 80220-3918, United States
Colorado Heart and Vascular, PC
Lakewood, Colorado, 80228, United States
Hartford Hospital
Hartford, Connecticut, 06102-8000, United States
Yale New Haven Hospital
New Have, Connecticut, 06510, United States
Heart Rhythm Solutions
Hollywood, Florida, 33021, United States
Baptist Health
Jacksonville, Florida, 32207, United States
Cardiovascular Institute of Northwest Florida
Panama City, Florida, 32405, United States
Heart & Vascular Institute of Florida
Safety Harbor, Florida, 34695-6604, United States
Heart Rhythm Consultants P.A. (Sarasota Memorial Research)
Sarasota, Florida, 34233, United States
Deaconess Specialty Physicians
Evansville, Indiana, 47710-1658, United States
Iowa Heart
Des Moines, Iowa, 50266, United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160-8500, United States
Norton Heart and Vascular Institute
Louisville, Kentucky, 40205-3373, United States
TidalHealth Peninsula Regional, Inc.
Salisbury, Maryland, 21804, United States
Associates in Cardiology PA
Silver Spring, Maryland, 20910-1265, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
Michigan Heart
Ypsilanti, Michigan, 48197-8633, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Missouri Cardiovascular Specialists
Columbia, Missouri, 65201-8023, United States
University Hospital of Missouri
Columbia, Missouri, 65212, United States
Saint Lukes Health System
Kansas City, Missouri, 64111-5934, United States
Washington University School of Medicine
St Louis, Missouri, 63110-1010, United States
Nebraska Medicine
Omaha, Nebraska, 68105, United States
Monmouth Cardiology Associates
Eatontown, New Jersey, 07724, United States
Presbyterian Heart Group
Albuquerque, New Mexico, 87106-4921, United States
South Shore University Hospital
Bay Shore, New York, 11706, United States
Huntington Hospital
Huntington, New York, 11743, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Northern Westchester Hospital
Mount Kisco, New York, 10549, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, 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
Lenox Hill Hospital
New York, New York, 10075, United States
Hudson Valley Heart Center
Poughkeepsie, New York, 12601-3923, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
WakeMed Health & Hospitals
Raleigh, North Carolina, 27610, United States
Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists
Akron, Ohio, 44304-1473, United States
The Christ Hospital Health Network
Cincinnati, Ohio, 45219, United States
St Lukes University Health Network
Bethlehem, Pennsylvania, 18015, United States
Saint Thomas Research Institute
Nashville, Tennessee, 37205-2018, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705-1852, United States
Consultants in Cardiology
Fort Worth, Texas, 76104-2821, United States
Heart Center of North Texas
Fort Worth, Texas, 76104, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215, United States
Clinique Rhone Durance
Avignon, France, France
Ch de La Region D'Annecy
Metz-Tessy, France, France
Nouvelles Cliniques Nantaises
Nantes, France, France
Chu Nord Saint-Étienne
Saint-Priest-en-Jarez, France, France
CHU de Brest
Brest, France
CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol
Caen, France
Générale de Santé - Hôpital Privé Saint Martin
Caen, France
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
Clermont-Ferrand, France
CHU de Dijon - Hospital Le Bocage
Dijon, France
CHRU La Rochelle
La Rochelle, France
Capio - Clinique du Tonkin
Villeurbanne, France
Hygeia Hospital
Athens, Greece
Athens Medical Center
Marousi, Greece
Policlinico Sant' Orsola - Malpighi
Bologna, Italy
Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"
Cosenza, Italy
Ospedale "Vito Fazzi" Lecce
Lecce, Italy
Azienda Ospedaliera Ospedale Niguarda Ca Granda
Milan, Italy
Presidio Ospedaliero Centrale - SS. Annunziata
Taranto, Italy
Azienda ospedaleria Santa Maria della Misericordia di Udine
Udine, Italy
Hospital da Senhora da Oliveira - Guimarães
Guimarães, Portugal
Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
Lisbon, Portugal
Centro Hospitalar Universitário de São João
Porto, Portugal
Hospital Distrital de Santarém
Santarém, Portugal
Národný ústav srdcových a cievnych chorôb, a.s. (NÚSCH, a.s.)
Bratislava, Slovakia
Hospital Universitario da Coruña
A Coruña, Spain
Hospital Universitario Clínico San Cecilio
Granada, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Complejo Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Spain
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Cardiopark Zurich
Zurich, Switzerland
University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
Birmingham, United Kingdom
Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital
Blackpool, United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, United Kingdom
Imperial College Healthcare NHS Trust - Hammersmith Hospital
London, United Kingdom
Central Manchester University Hospitals NHS - Manchester Royal Infirmary
Manchester, United Kingdom
The James Cook University Hospital - South Tees Hospitals NHS
Middlesbrough, United Kingdom
Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General
Sheffield, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2020
First Posted
July 28, 2020
Study Start
August 1, 2020
Primary Completion
December 6, 2024
Study Completion (Estimated)
January 31, 2028
Last Updated
October 20, 2025
Record last verified: 2025-10