Heart FailureNCT04489225
Personalized Therapy Study - HFRS (TriageHF) Post Approval Study
An observational study of Heart Failure, run by Medtronic at 92 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Observational
- How many people
- 2,200 participants
- Where
- 92 sitesin 9 countries
- Study dates
- 1 Aug 2020to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
92 sites in 9 countries.
92 sites in 9 countries
United States51 sites
Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists
Akron, Ohio, 44304-1473
Presbyterian Heart Group
Albuquerque, New Mexico, 87106-4921
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705-1852
South Shore University Hospital
Bay Shore, New York, 11706
St Lukes University Health Network
Bethlehem, Pennsylvania, 18015
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Southwest EP
Chandler, Arizona, 85226
Chula Vista Cardiac Center
Chula Vista, California, 91910
The Christ Hospital Health Network
Cincinnati, Ohio, 45219
Colorado Springs Cardiology
Colorado Springs, Colorado, 80907
Missouri Cardiovascular Specialists
Columbia, Missouri, 65201-8023
University Hospital of Missouri
Columbia, Missouri, 65212
Denver Heart
Denver, Colorado, 80220-3918
Iowa Heart
Des Moines, Iowa, 50266
Monmouth Cardiology Associates
Eatontown, New Jersey, 07724
Deaconess Specialty Physicians
Evansville, Indiana, 47710-1658
Consultants in Cardiology
Fort Worth, Texas, 76104-2821
Heart Center of North Texas
Fort Worth, Texas, 76104
Hartford Hospital
Hartford, Connecticut, 06102-8000
Heart Rhythm Solutions
Hollywood, Florida, 33021
Huntington Hospital
Huntington, New York, 11743
Baptist Health
Jacksonville, Florida, 32207
The University of Kansas Medical Center
Kansas City, Kansas, 66160-8500
Saint Lukes Health System
Kansas City, Missouri, 64111-5934
Colorado Heart and Vascular, PC
Lakewood, Colorado, 80228
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
Saint Vincent Heart Clinic Arkansas
Little Rock, Arkansas, 72205-6202
Norton Heart and Vascular Institute
Louisville, Kentucky, 40205-3373
North Shore University Hospital
Manhasset, New York, 11030
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215
Northern Westchester Hospital
Mount Kisco, New York, 10549
Saint Thomas Research Institute
Nashville, Tennessee, 37205-2018
Yale New Haven Hospital
New Have, Connecticut, 06510
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
New York-Presbyterian Hospital/Weill-Cornell Medical Center
New York, New York, 10021
NewYork-Presbyterian/Columbia University Irving Medical Center
New York, New York, 10032
Lenox Hill Hospital
New York, New York, 10075
Nebraska Medicine
Omaha, Nebraska, 68105
Cardiovascular Institute of Northwest Florida
Panama City, Florida, 32405
Hudson Valley Heart Center
Poughkeepsie, New York, 12601-3923
WakeMed Health & Hospitals
Raleigh, North Carolina, 27610
Mayo Clinic
Rochester, Minnesota, 55905
Heart & Vascular Institute of Florida
Safety Harbor, Florida, 34695-6604
TidalHealth Peninsula Regional, Inc.
Salisbury, Maryland, 21804
Heart Rhythm Consultants P.A. (Sarasota Memorial Research)
Sarasota, Florida, 34233
Associates in Cardiology PA
Silver Spring, Maryland, 20910-1265
Washington University School of Medicine
St Louis, Missouri, 63110-1010
Staten Island University Hospital
Staten Island, New York, 10305
Cardiovascular Consultants Medical Group
Van Nuys, California, 91405
Cardiology Associates Medical Group
Ventura, California, 93003-2840
Michigan Heart
Ypsilanti, Michigan, 48197-8633
France11 sites
Clinique Rhone Durance
Avignon, France
CHU de Brest
Brest
CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol
Caen
Générale de Santé - Hôpital Privé Saint Martin
Caen
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
Clermont-Ferrand
CHU de Dijon - Hospital Le Bocage
Dijon
CHRU La Rochelle
La Rochelle
Ch de La Region D'Annecy
Metz-Tessy, France
Nouvelles Cliniques Nantaises
Nantes, France
Chu Nord Saint-Étienne
Saint-Priest-en-Jarez, France
Capio - Clinique du Tonkin
Villeurbanne
Spain8 sites
Hospital Universitario da Coruña
A Coruña
Hospital Universitario Clínico San Cecilio
Granada
Hospital Universitario Virgen de las Nieves
Granada
Hospital Universitario 12 de Octubre
Madrid
Complejo Universitario de Salamanca
Salamanca
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago
Hospital Clínico Universitario de Valladolid
Valladolid
United Kingdom7 sites
University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
Birmingham
Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital
Blackpool
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool
Imperial College Healthcare NHS Trust - Hammersmith Hospital
London
Central Manchester University Hospitals NHS - Manchester Royal Infirmary
Manchester
The James Cook University Hospital - South Tees Hospitals NHS
Middlesbrough
Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General
Sheffield
Italy6 sites
Policlinico Sant' Orsola - Malpighi
Bologna
Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"
Cosenza
Ospedale "Vito Fazzi" Lecce
Lecce
Azienda Ospedaliera Ospedale Niguarda Ca Granda
Milan
Presidio Ospedaliero Centrale - SS. Annunziata
Taranto
Azienda ospedaleria Santa Maria della Misericordia di Udine
Udine
Portugal4 sites
Hospital da Senhora da Oliveira - Guimarães
Guimarães
Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
Lisbon
Centro Hospitalar Universitário de São João
Porto
Hospital Distrital de Santarém
Santarém
Switzerland2 sites
Hôpitaux Universitaires de Genève
Geneva
Cardiopark Zurich
Zurich
Slovakia1 site
Národný ústav srdcových a cievnych chorôb, a.s. (NÚSCH, a.s.)
Bratislava
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Observational
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational only without any intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 5 years
Secondary outcomes (1)
Number of HF hospitalization or HF related deaths
Summarize the number of HF hospitalization or HF related deaths that were not preceded by a High-Risk Status.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Aug 2020
- Primary completion6 Dec 2024
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by MedtronicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489225
- Sponsor's protocol ID
- HFRS PAS
- Status last verified
- Oct 2025
- First submitted
- 23 Jul 2020
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yee R, Love CJ, Kaiser DW, Birgersdotter-Green U, Cha YM, Singh JP, Liu S, Zhang Y, Chung ES. Rationale and Design of the Personalized Therapy Study: Evaluating Real-World Performance of Two Automated Defibrillation Therapy Algorithms. J Card Fail. 2025 May;31(5):824-832. doi: 10.1016/j.cardfail.2024.11.011. Epub 2024 Dec 16.
PubMed 39694452
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Therapy Study - Heart Failure Risk Status (TriageHF) Post Approval Study
- ClinicalTrials.gov ID
- NCT04489225
- Acronym / sponsor ID
- HFRS PAS
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: ObservationalThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational only without any intervention | Other | Observational |
Primary outcome
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
1 secondary outcome
Number of HF hospitalization or HF related deaths
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Derived from this study: PubMed 39694452Yee R, Love CJ, Kaiser DW, Birgersdotter-Green U, Cha YM, Singh JP, Liu S, Zhang Y, Chung ES. Rationale and Design of the Personalized Therapy Study: Evaluating Real-World Performance of Two Automated Defibrillation Therapy Algorithms. J Card Fail. 2025 May;31(5):824-832. doi: 10.1016/j.cardfail.2024.11.011. Epub 2024 Dec 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
92 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Medtronic at 92 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 92 sites in United States, France, Spain, United Kingdom, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04489225, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.