Personalized Therapy Study - HFRS (TriageHF) Post Approval Study
- Conditions
- Heart Failure
- Interventions
- Other: Observational
- Registration Number
- NCT04489225
- Lead Sponsor
- Medtronic
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2200
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (92)
Lenox Hill Hospital
🇺🇸New York City, New York, United States
New York-Presbyterian Hospital/Weill-Cornell Medical Center
🇺🇸New York, New York, United States
NewYork-Presbyterian/Columbia University Irving Medical Center
🇺🇸New York, New York, United States
Hudson Valley Heart Center
🇺🇸Poughkeepsie, New York, United States
Staten Island University Hospital
🇺🇸Staten Island, New York, United States
WakeMed Health & Hospitals
🇺🇸Raleigh, North Carolina, United States
Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists
🇺🇸Akron, Ohio, United States
The Christ Hospital Health Network
🇺🇸Cincinnati, Ohio, United States
St Lukes University Health Network
🇺🇸Bethlehem, Pennsylvania, United States
Saint Thomas Research Institute
🇺🇸Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States
Consultants in Cardiology
🇺🇸Fort Worth, Texas, United States
Heart Center of North Texas
🇺🇸Fort Worth, Texas, United States
Aurora Cardiovascular Services
🇺🇸Milwaukee, Wisconsin, United States
Clinique Rhone Durance
🇫🇷Avignon, 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
Ch de La Region D'Annecy
🇫🇷Metz-Tessy, France
Nouvelles Cliniques Nantaises
🇫🇷Nantes, France
Chu Nord Saint-Étienne
🇫🇷Saint-Priest-en-Jarez, France
Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"
🇮🇹Cosenza, Italy
Capio - Clinique du Tonkin
🇫🇷Villeurbanne, France
Hygeia Hospital
🇬🇷Athens, Greece
Athens Medical Center
🇬🇷Maroúsi, Greece
Policlinico Sant' Orsola - Malpighi
🇮🇹Bologna, Italy
Ospedale "Vito Fazzi" Lecce
🇮🇹Lecce, Italy
Azienda Ospedaliera Ospedale Niguarda Ca Granda
🇮🇹Milano, Italy
Hospital Distrital de Santarém
🇵🇹Santarém, Portugal
Národný ústav srdcových a cievnych chorôb, a.s. (NÚSCH, a.s.)
🇸🇰Bratislava, Slovakia
Presidio Ospedaliero Centrale - SS. Annunziata
🇮🇹Taranto, Italy
Azienda ospedaleria Santa Maria della Misericordia di Udine
🇮🇹Udine, Italy
Complejo Hospitalario Universitario de Santiago de Compostela
🇪🇸Santiago, Spain
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 Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Iowa Heart
🇺🇸Des Moines, Iowa, United States
Norton Heart and Vascular Institute
🇺🇸Louisville, Kentucky, United States
Southwest EP
🇺🇸Chandler, Arizona, United States
Saint Vincent Heart Clinic Arkansas
🇺🇸Little Rock, Arkansas, United States
Chula Vista Cardiac Center
🇺🇸Chula Vista, California, United States
Cardiovascular Consultants Medical Group
🇺🇸Van Nuys, California, United States
Cardiology Associates Medical Group
🇺🇸Ventura, California, United States
Colorado Springs Cardiology
🇺🇸Colorado Springs, Colorado, United States
Colorado Heart and Vascular, PC
🇺🇸Lakewood, Colorado, United States
Denver Heart
🇺🇸Denver, Colorado, United States
Yale New Haven Hospital
🇺🇸New Have, Connecticut, United States
Baptist Health
🇺🇸Jacksonville, Florida, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Heart Rhythm Solutions
🇺🇸Hollywood, Florida, United States
Cardiovascular Institute of Northwest Florida
🇺🇸Panama City, Florida, United States
Heart & Vascular Institute of Florida
🇺🇸Safety Harbor, Florida, United States
Heart Rhythm Consultants P.A. (Sarasota Memorial Research)
🇺🇸Sarasota, Florida, United States
Deaconess Specialty Physicians
🇺🇸Evansville, Indiana, United States
The University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
TidalHealth Peninsula Regional, Inc.
🇺🇸Salisbury, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Associates in Cardiology PA
🇺🇸Silver Spring, Maryland, United States
Sparrow Clinical Research Institute
🇺🇸Lansing, Michigan, United States
University Hospital of Missouri
🇺🇸Columbia, Missouri, United States
Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Missouri Cardiovascular Specialists
🇺🇸Columbia, Missouri, United States
Saint Lukes Health System
🇺🇸Kansas City, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Nebraska Medicine
🇺🇸Omaha, Nebraska, United States
Monmouth Cardiology Associates
🇺🇸Eatontown, New Jersey, United States
Presbyterian Heart Group
🇺🇸Albuquerque, New Mexico, United States
South Shore University Hospital
🇺🇸Bay Shore, New York, United States
Huntington Hospital
🇺🇸Huntington, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Northern Westchester Hospital
🇺🇸Mount Kisco, New York, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Hospital Universitario da Coruña
🇪🇸Coruña, Spain
Hospital Universitario Clínico San Cecilio
🇪🇸Granada, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Complejo Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Universitario Nuestra Señora de Candelaria
🇪🇸Tenerife, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
Hôpitaux Universitaires de Genève
🇨🇭Geneve, Switzerland
Cardiopark Zurich
🇨🇭Zürich, Switzerland
University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital
🇬🇧Blackpool, 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