Personalized Therapy Study - HFRS (TriageHF) Post Approval Study
Sponsor
Medtronic (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04489225
Collaborator
(none)
2,200
114
78
19.3
0.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Study Type:
Observational
Anticipated Enrollment
:
2200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Personalized Therapy Study - Heart Failure Risk Status (TriageHF) Post Approval Study
Actual Study Start Date
:
Aug 1, 2020
Anticipated Primary Completion Date
:
Jan 31, 2025
Anticipated Study Completion Date
:
Jan 31, 2027
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure [Up to 5 years]
To estimate the positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure
Secondary Outcome Measures
- Number of HF hospitalization or HF related deaths [Up to 5 years]
Summarize the number of HF hospitalization or HF related deaths that were not preceded by a High-Risk Status.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alaska Heart | Anchorage | Alaska | United States | 99508-4673 |
| 2 | Southwest EP | Chandler | Arizona | United States | 85226 |
| 3 | Cardiology Associates of Northeast Arkansas | Jonesboro | Arkansas | United States | 72410-4163 |
| 4 | Saint Vincent Heart Clinic Arkansas | Little Rock | Arkansas | United States | 72205-6202 |
| 5 | Chula Vista Cardiac Center | Chula Vista | California | United States | 91910 |
| 6 | San Diego Arrhythmia Associates | San Diego | California | United States | 92103-2120 |
| 7 | COR Healthcare | Torrance | California | United States | 90505 |
| 8 | Cardiovascular Consultants Medical Group | Van Nuys | California | United States | 91405 |
| 9 | Cardiology Associates Medical Group | Ventura | California | United States | 93003-2840 |
| 10 | Colorado Springs Cardiology | Colorado Springs | Colorado | United States | 80907 |
| 11 | Denver Heart | Denver | Colorado | United States | 80220-3918 |
| 12 | Colorado Heart and Vascular, PC | Lakewood | Colorado | United States | 80228 |
| 13 | Hartford Hospital | Hartford | Connecticut | United States | 06102-8000 |
| 14 | Yale New Haven Hospital | New Haven | Connecticut | United States | 06510 |
| 15 | Clearwater Cardiovascular Consultants | Clearwater | Florida | United States | 33756-3356 |
| 16 | Heart Rhythm Solutions | Hollywood | Florida | United States | 33021 |
| 17 | Baptist Health | Jacksonville | Florida | United States | 32207 |
| 18 | Cardiovascular Institute of Northwest Florida | Panama City | Florida | United States | 32405 |
| 19 | Heart & Vascular Institute of Florida | Safety Harbor | Florida | United States | 34695-6604 |
| 20 | Heart Rhythm Consultants P.A. (Sarasota Memorial Research) | Sarasota | Florida | United States | 34233 |
| 21 | Deaconess Specialty Physicians | Evansville | Indiana | United States | 47710-1658 |
| 22 | Iowa Heart | Des Moines | Iowa | United States | 50266 |
| 23 | The University of Kansas Medical Center | Kansas City | Kansas | United States | 66160-8500 |
| 24 | Saint Elizabeth Healthcare | Edgewood | Kentucky | United States | 41017-3439 |
| 25 | Norton Heart Specialists | Louisville | Kentucky | United States | 40205-3373 |
| 26 | Our Lady of the Lake Office of Research | Baton Rouge | Louisiana | United States | 70808 |
| 27 | MedStar Health Research Institute | Baltimore | Maryland | United States | 21237-3958 |
| 28 | TidalHealth Peninsula Regional, Inc. | Salisbury | Maryland | United States | 21804 |
| 29 | Associates in Cardiology PA | Silver Spring | Maryland | United States | 20910-1265 |
| 30 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114-2621 |
| 31 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 32 | Sparrow Clinical Research Institute | Lansing | Michigan | United States | 48912 |
| 33 | UP Health System - Marquette | Marquette | Michigan | United States | 49855-2705 |
| 34 | Michigan Heart | Ypsilanti | Michigan | United States | 48197-8633 |
| 35 | North Memorial Heart and Vascular Institute | Robbinsdale | Minnesota | United States | 55422 |
| 36 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 37 | Missouri Cardiovascular Specialists | Columbia | Missouri | United States | 65201-8023 |
| 38 | University Hospital of Missouri | Columbia | Missouri | United States | 65212 |
| 39 | Saint Lukes Health System | Kansas City | Missouri | United States | 64111-5934 |
| 40 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110-1010 |
| 41 | Nebraska Medicine | Omaha | Nebraska | United States | 68105 |
| 42 | Monmouth Cardiology Associates | Eatontown | New Jersey | United States | 07724 |
| 43 | Presbyterian Heart Group | Albuquerque | New Mexico | United States | 87106-4921 |
| 44 | South Shore University Hospital | Bay Shore | New York | United States | 11706 |
| 45 | Huntington Hospital | Huntington | New York | United States | 11743 |
| 46 | North Shore University Hospital | Manhasset | New York | United States | 11030 |
| 47 | Northern Westchester Hospital | Mount Kisco | New York | United States | 10549 |
| 48 | Long Island Jewish Medical Center | New Hyde Park | New York | United States | 11040 |
| 49 | New York-Presbyterian Hospital/Weill-Cornell Medical Center | New York | New York | United States | 10021 |
| 50 | NewYork-Presbyterian/Columbia University Irving Medical Center | New York | New York | United States | 10032 |
| 51 | Lenox Hill Hospital | New York | New York | United States | 10075 |
| 52 | Hudson Valley Heart Center | Poughkeepsie | New York | United States | 12601-3923 |
| 53 | Staten Island University Hospital | Staten Island | New York | United States | 10305 |
| 54 | Duke University Medical Center (DUMC) | Durham | North Carolina | United States | 27705 |
| 55 | WakeMed Health & Hospitals | Raleigh | North Carolina | United States | 27610 |
| 56 | Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists | Akron | Ohio | United States | 44304-1473 |
| 57 | The Christ Hospital Health Network | Cincinnati | Ohio | United States | 45219 |
| 58 | University of Cincinnati | Cincinnati | Ohio | United States | 45267-0542 |
| 59 | Cleveland Clinic | Cleveland | Ohio | United States | 44195-0001 |
| 60 | St Lukes University Health Network | Bethlehem | Pennsylvania | United States | 18015 |
| 61 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822 |
| 62 | UPMC Heart and Vascular Institute at UPMC Hamot | Erie | Pennsylvania | United States | 16507-1579 |
| 63 | Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | United States | 18711 |
| 64 | Saint Thomas Research Institute | Nashville | Tennessee | United States | 37205-2018 |
| 65 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232-8802 |
| 66 | Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | United States | 78705-1852 |
| 67 | Consultants in Cardiology | Fort Worth | Texas | United States | 76104-2821 |
| 68 | Heart Center of North Texas | Fort Worth | Texas | United States | 76104 |
| 69 | EP Heart | The Woodlands | Texas | United States | 77384-4103 |
| 70 | Kootenai Heart Clinics Northwest | Spokane | Washington | United States | 99204-2352 |
| 71 | Aurora Cardiovascular Services | Milwaukee | Wisconsin | United States | 53215 |
| 72 | Clinique Rhone Durance | Avignon | France | ||
| 73 | Centre Hospitalier de la Côte Basque | Bayonne | France | ||
| 74 | CHU de Brest | Brest | France | ||
| 75 | CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol | Caen | France | ||
| 76 | Générale de Santé - Hôpital Privé Saint Martin | Caen | France | ||
| 77 | Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied | Clermont Ferrand | France | ||
| 78 | CHU de Dijon - Hospital Le Bocage | Dijon | France | ||
| 79 | CHRU La Rochelle | La Rochelle | France | ||
| 80 | Hopital prive Clairval - Ramsay Sante | Marseille | France | ||
| 81 | Ch de La Region D'Annecy | Metz-Tessy | France | ||
| 82 | Nouvelles Cliniques Nantaises | Nantes | France | ||
| 83 | Chu Nord Saint-Étienne | Saint-Priest-en-Jarez | France | ||
| 84 | Capio - Clinique du Tonkin | Villeurbanne | France | ||
| 85 | Hygeia Hospital | Athens | Greece | ||
| 86 | Athens Medical Center | Maroúsi | Greece | ||
| 87 | Policlinico Sant' Orsola - Malpighi | Bologna | Italy | ||
| 88 | Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari" | Cosenza | Italy | ||
| 89 | Ospedale "Vito Fazzi" Lecce | Lecce | Italy | ||
| 90 | Azienda Ospedaliera Ospedale Niguarda Ca Granda | Milano | Italy | ||
| 91 | Presidio Ospedaliero Centrale - SS. Annunziata | Taranto | Italy | ||
| 92 | Azienda ospedaleria Santa Maria della Misericordia di Udine | Udine | Italy | ||
| 93 | Hospital da Senhora da Oliveira - Guimarães | Guimarães | Portugal | ||
| 94 | Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE | Lisbon | Portugal | ||
| 95 | Centro Hospitalar Universitário de São João | Porto | Portugal | ||
| 96 | Hospital Distrital de Santarém | Santarém | Portugal | ||
| 97 | Národný ústav srdcových a cievnych chorôb, a.s. (NÚSCH, a.s.) | Bratislava | Slovakia | ||
| 98 | Hospital Universitario da Coruña | Coruña | Spain | ||
| 99 | Hospital Universitario Clínico San Cecilio | Granada | Spain | ||
| 100 | Hospital Universitario Virgen de las Nieves | Granada | Spain | ||
| 101 | Hospital Universitario 12 de Octubre | Madrid | Spain | ||
| 102 | Complejo Universitario de Salamanca | Salamanca | Spain | ||
| 103 | Complejo Hospitalario Universitario de Santiago de Compostela | Santiago | Spain | ||
| 104 | Hospital Universitario Nuestra Señora de Candelaria | Tenerife | Spain | ||
| 105 | Hospital Clínico Universitario de Valladolid | Valladolid | Spain | ||
| 106 | Hôpitaux Universitaires de Genève | Geneve | Switzerland | ||
| 107 | Cardiopark Zurich | Zürich | Switzerland | ||
| 108 | University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital | Birmingham | United Kingdom | ||
| 109 | Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital | Blackpool | United Kingdom | ||
| 110 | Liverpool Heart and Chest Hospital NHS Foundation Trust | Liverpool | United Kingdom | ||
| 111 | Imperial College Healthcare NHS Trust - Hammersmith Hospital | London | United Kingdom | ||
| 112 | Central Manchester University Hospitals NHS - Manchester Royal Infirmary | Manchester | United Kingdom | ||
| 113 | The James Cook University Hospital - South Tees Hospitals NHS | Middlesbrough | United Kingdom | ||
| 114 | Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General | Sheffield | United Kingdom |
Sponsors and Collaborators
- Medtronic
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Medtronic
ClinicalTrials.gov Identifier:
NCT04489225
Other Study ID Numbers:
- HFRS PAS
First Posted:
Jul 28, 2020
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: