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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | Observational only without any intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest EP | Chandler | Arizona | 85226 | United States | ||
| Saint Vincent Heart Clinic Arkansas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39694452 | Derived | 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. |
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| 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 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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