Personalized Therapy Study - HFRS (TriageHF) Post Approval Study

August 29, 2023 updated by: Medtronic

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.

Study Overview

Status

Recruiting

Conditions

Heart Failure

Intervention / Treatment

Other: Observational

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 Type

Observational

Enrollment (Estimated)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: PSR Study Team
Phone Number: 1-800-633-8766
Email: rs.productsurveillanceregistry@medtronic.com

Study Locations

France
- - Avignon, France
    - Recruiting
    - Clinique Rhône Durance
    - Principal Investigator:
      
      Francious Xavier Hager, M.D.
  - Bayonne, France
    - Not yet recruiting
    - Centre Hospitalier de la Côte Basque
    - Principal Investigator:
      
      Julien Laborderie, M.D.
  - Brest, France
    - Recruiting
    - CHU de Brest
    - Principal Investigator:
      
      Jacques Mansourati
  - Caen, France
    - Recruiting
    - CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol
    - Principal Investigator:
      
      Pierre Ollitrault, M.D.
  - Caen, France
    - Recruiting
    - Générale de Santé - Hôpital Privé Saint Martin
    - Principal Investigator:
      
      Alain Lebon, M.D.
  - Clermont Ferrand, France
    - Recruiting
    - Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
    - Principal Investigator:
      
      Romain Eschalier, Pr
  - Dijon, France
    - Recruiting
    - CHU de Dijon - Hospital Le Bocage
    - Principal Investigator:
      
      Geraldine Bertaux, M.D.
  - La Rochelle, France
    - Recruiting
    - CHRU La Rochelle
    - Principal Investigator:
      
      Antoine Milhem, M.D.
  - Marseille, France
    - Not yet recruiting
    - Hopital prive Clairval - Ramsay Sante
    - Principal Investigator:
      
      Alexis Mechulan, M.D.
  - Metz-Tessy, France
    - Recruiting
    - CH de la Region d'Annecy
    - Principal Investigator:
      
      Antoine Dompnier, M.D.
  - Nantes, France
    - Recruiting
    - Nouvelles Cliniques Nantaises
    - Principal Investigator:
      
      Daniel Gras, M.D.
  - Saint-Priest-en-Jarez, France
    - Recruiting
    - Chu Nord Saint-Étienne
    - Principal Investigator:
      
      Antoine De Costa, Pr
  - Villeurbanne, France
    - Recruiting
    - Capio - Clinique du Tonkin
    - Principal Investigator:
      
      Herve' Poty, M.D.
Greece
- - Athens, Greece
    - Recruiting
    - Hygeia Hospital
    - Principal Investigator:
      
      Theodoros D Apostolopoulos, MD
  - Maroúsi, Greece
    - Recruiting
    - Athens Medical Center
    - Principal Investigator:
      
      Dimitrios Tsiachris, MD
Italy
- - Bologna, Italy
    - Recruiting
    - Policlinico Sant' Orsola - Malpighi
    - Principal Investigator:
      
      Igor Diemberger, MD
  - Cosenza, Italy
    - Recruiting
    - Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"
    - Principal Investigator:
      
      Giovanni Bisignani, MD
  - Lecce, Italy
    - Recruiting
    - Ospedale "Vito Fazzi" Lecce
    - Principal Investigator:
      
      Ennio Carmine Luigi Pisanò, MD
  - Milano, Italy
    - Recruiting
    - Azienda Ospedaliera Ospedale Niguarda CA Granda
    - Principal Investigator:
      
      Guiseppe Cattafi, M.D.
  - Taranto, Italy
    - Recruiting
    - Presidio Ospedaliero Centrale - SS. Annunziata
    - Principal Investigator:
      
      Giovanni Luzzi, MD
  - Udine, Italy
    - Recruiting
    - Azienda ospedaleria Santa Maria della Misericordia di Udine
    - Principal Investigator:
      
      Domenico Facchin, M.D.
Portugal
- - Guimarães, Portugal
    - Recruiting
    - Hospital da Senhora da Oliveira - Guimarães
    - Principal Investigator:
      
      Victor Sanfins, MD
  - Lisbon, Portugal
    - Recruiting
    - Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
    - Principal Investigator:
      
      João de Sousa, MD
  - Porto, Portugal
    - Recruiting
    - Centro Hospitalar Universitário de São João
    - Principal Investigator:
      
      Luís Adão, MD
  - Santarém, Portugal
    - Recruiting
    - Hospital Distrital de Santarém
    - Principal Investigator:
      
      Vitor Martins, MD
Slovakia
- - Bratislava, Slovakia
    - Recruiting
    - Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)
    - Principal Investigator:
      
      Michal Sasov, M.D.
Spain
- - Coruña, Spain
    - Recruiting
    - Hospital Universitario da Coruña
    - Principal Investigator:
      
      Luisa Perez Alvarez, M.D.
  - Granada, Spain
    - Recruiting
    - Hospital Universitario Virgen de las Nieves
    - Principal Investigator:
      
      Pablo Sánchez, MD
  - Granada, Spain
    - Recruiting
    - Hospital Universitario Clinico San Cecilio
    - Principal Investigator:
      
      Sebastián Giacomán, MD
  - Madrid, Spain
    - Recruiting
    - Hospital Universitario 12 de Octubre
    - Principal Investigator:
      
      Rafael Salguero Bodes, M.D.
  - Salamanca, Spain
    - Recruiting
    - Complejo Universitario de Salamanca
    - Principal Investigator:
      
      Javier Jiménez Candil, MD
  - Santiago, Spain
    - Recruiting
    - Complejo Hospitalario Universitario de Santiago de Compostela
    - Principal Investigator:
      
      Jose Luis Martinez Sande, MD
  - Tenerife, Spain
    - Recruiting
    - Hospital Universitario Nuestra Señora de Candelaria
    - Principal Investigator:
      
      Luis Alvarez, MD
  - Valladolid, Spain
    - Recruiting
    - Hospital Clínico Universitario de Valladolid
    - Principal Investigator:
      
      Maria Sandin, MD
Switzerland
- - Geneve, Switzerland
    - Recruiting
    - Hôpitaux Universitaires de Genève
    - Principal Investigator:
      
      Haran Burri, M.D.
  - Zürich, Switzerland
    - Recruiting
    - Cardiopark Zurich
    - Principal Investigator:
      
      Eva Bühlmann, M.D.
United Kingdom
- - Birmingham, United Kingdom
    - Recruiting
    - University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
    - Principal Investigator:
      
      Francisco L Leon
  - Blackpool, United Kingdom
    - Recruiting
    - Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital
    - Principal Investigator:
      
      Alison Seed, MD
  - Liverpool, United Kingdom
    - Recruiting
    - Liverpool Heart and Chest Hospital NHS Foundation Trust
    - Principal Investigator:
      
      Archana Rao, M.D.
  - London, United Kingdom
    - Recruiting
    - Imperial College Healthcare NHS Trust - Hammersmith Hospital
    - Principal Investigator:
      
      Zachary Whinnett, M.D.
  - Manchester, United Kingdom
    - Recruiting
    - Central Manchester University Hospitals NHS - Manchester Royal Infirmary
    - Principal Investigator:
      
      Amir Zaidi, MD
  - Middlesbrough, United Kingdom
    - Recruiting
    - The James Cook University Hospital - South Tees Hospitals NHS
    - Principal Investigator:
      
      Nicholas J Linker, MD
  - Sheffield, United Kingdom
    - Recruiting
    - Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General
    - Principal Investigator:
      
      Lewis Nigel, MD
United States
- Alaska
  - Anchorage, Alaska, United States, 99508-4673
    - Not yet recruiting
    - Alaska Heart
    - Contact:
      
      Study Coordinator
    - Contact:
      
      Phone Number: (907) 561-3211
- Arizona
  - Chandler, Arizona, United States, 85226
    - Recruiting
    - Southwest EP
    - Contact:
      
      Study Coordinator
      
      Phone Number: 480-776-6844
    - Principal Investigator:
      
      Drory Tendler, M.D.
- Arkansas
  - Jonesboro, Arkansas, United States, 72410-4163
    - Not yet recruiting
    - Cardiology Associates of Northeast Arkansas
    - Contact:
      
      Study Coordinator
      
      Phone Number: 870-207-3827
  - Little Rock, Arkansas, United States, 72205-6202
    - Recruiting
    - Saint Vincent Heart Clinic Arkansas
    - Contact:
      
      Study coordinator
      
      Phone Number: 501-255-6030
    - Principal Investigator:
      
      Mangaraju Chakka, M.D.
- California
  - Chula Vista, California, United States, 91910
    - Recruiting
    - Chula Vista Cardiac Center
    - Contact:
      
      Study Coordinator
      
      Phone Number: 619-934-3260
    - Principal Investigator:
      
      Brett Berman, M.D.
  - San Diego, California, United States, 92103-2120
    - Not yet recruiting
    - San Diego Arrhythmia Associates
    - Contact:
      
      Study Coordinator
      
      Phone Number: 619-297-0014
  - Torrance, California, United States, 90505
    - Not yet recruiting
    - COR Healthcare
    - Contact:
      
      Study Coordinator
      
      Phone Number: 310-792-5800
  - Van Nuys, California, United States, 91405
    - Recruiting
    - Cardiovascular Consultants Medical Group
    - Contact:
      
      Study Coordinator
      
      Phone Number: 818-782-5041
    - Principal Investigator:
      
      Isaac Wiener, M.D.
  - Ventura, California, United States, 93003-2840
    - Recruiting
    - Cardiology Associates Medical Group
    - Contact:
      
      Study Coordinator
      
      Phone Number: 818-309-5542
    - Principal Investigator:
      
      Jonathan Dukes, M.D.
- Colorado
  - Colorado Springs, Colorado, United States, 80907
    - Recruiting
    - Colorado Springs Cardiology
    - Contact:
      
      Study Coordinator
      
      Phone Number: 719-776-2514
    - Principal Investigator:
      
      Christopher Cole, M.D.
  - Denver, Colorado, United States, 80220-3918
    - Recruiting
    - Denver Heart
    - Contact:
      
      Study Coordinator
      
      Phone Number: 303-331-9121
    - Principal Investigator:
      
      Christopher Stees, M.D.
  - Lakewood, Colorado, United States, 80228
    - Recruiting
    - Colorado Heart and Vascular, PC
    - Contact:
      
      Study Coordinator
      
      Phone Number: 303-595-2727
    - Principal Investigator:
      
      Ganesh Venkataraman, M.D.
- Connecticut
  - Hartford, Connecticut, United States, 06102-8000
    - Recruiting
    - Hartford Hospital
    - Contact:
      
      Study Coordinator
      
      Phone Number: 860-545-1506
    - Principal Investigator:
      
      Steve Zweibel, M.D.
  - New Haven, Connecticut, United States, 06510
    - Recruiting
    - Yale New Haven Hospital
    - Contact:
      
      Study Coordinator
      
      Phone Number: 203-466-8177
    - Principal Investigator:
      
      Rachel Lampert, M.D.
- Florida
  - Clearwater, Florida, United States, 33756-3356
    - Not yet recruiting
    - Clearwater Cardiovascular Consultants
    - Contact:
      
      Study Coordinator
    - Contact:
      
      Phone Number: (727) 451-1683
  - Hollywood, Florida, United States, 33021
    - Recruiting
    - Heart Rhythm Solutions
    - Contact:
      
      Primary Coordinator
      
      Phone Number: 954-707-5200
    - Principal Investigator:
      
      Awais Humayun, M.D.
  - Jacksonville, Florida, United States, 32207
    - Recruiting
    - Baptist Health
    - Contact:
      
      Study Coordinator
      
      Phone Number: 904-271-6343
    - Principal Investigator:
      
      Venkata Sagi, M.D.
  - Panama City, Florida, United States, 32405
    - Recruiting
    - Cardiovascular Institute of Northwest Florida
    - Contact:
      
      Study Coordinator
      
      Phone Number: 850-769-0329
    - Principal Investigator:
      
      Nghia Hoang, M.D.
  - Safety Harbor, Florida, United States, 34695-6604
    - Not yet recruiting
    - Heart & Vascular Institute of Florida
    - Contact:
      
      Study Coordinator
      
      Phone Number: 727-512-8047
  - Sarasota, Florida, United States, 34233
    - Recruiting
    - Heart Rhythm Consultants P.A. (Sarasota Memorial Research)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 941-917-1669
    - Principal Investigator:
      
      Antonio Moretta, M.D.
- Indiana
  - Evansville, Indiana, United States, 47710-1658
    - Recruiting
    - Deaconess Specialty Physicians
    - Principal Investigator:
      
      Chandrashekar Kumbar, M.D.
    - Contact:
      
      Study Coordinator
      
      Phone Number: 812-490-4505
- Iowa
  - Des Moines, Iowa, United States, 50266
    - Recruiting
    - Iowa Heart
    - Contact:
      
      Study Coordinator
      
      Phone Number: 515-633-3600
    - Principal Investigator:
      
      Dwayne Campbell, M.D.
- Kansas
  - Kansas City, Kansas, United States, 66160-8500
    - Recruiting
    - The University of Kansas Medical Center
    - Contact:
      
      Study Coordinator
      
      Phone Number: 913-588-5000
    - Principal Investigator:
      
      Martin Emert, M.D.
- Kentucky
  - Edgewood, Kentucky, United States, 41017-3439
    - Not yet recruiting
    - Saint Elizabeth Healthcare
    - Contact:
      
      Study Coordinator
      
      Phone Number: 859-301-4729
  - Louisville, Kentucky, United States, 40205-3373
    - Recruiting
    - Norton Heart Specialists
    - Contact:
      
      Study Coordinator
      
      Phone Number: 12520 502-891-8640
    - Principal Investigator:
      
      Robert Schwartz, M.D.
- Louisiana
  - Baton Rouge, Louisiana, United States, 70808
    - Not yet recruiting
    - Our Lady of the Lake Office of Research
    - Contact:
      
      Study Coordinator
      
      Phone Number: 225-765-7659
- Maryland
  - Salisbury, Maryland, United States, 21804
    - Recruiting
    - TidalHealth Peninsula Regional, Inc.
    - Contact:
      
      Study Coordinator
      
      Phone Number: 410-334-2333
    - Principal Investigator:
      
      Steven Hearne, M.D.
  - Silver Spring, Maryland, United States, 20910-1265
    - Recruiting
    - Associates in Cardiology PA
    - Contact:
      
      Study Coordinator
      
      Phone Number: 301-681-5700
    - Principal Investigator:
      
      Michael Lincoln, M.D.
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Recruiting
    - Brigham and Women's Hospital
    - Contact:
      
      Study Coordinator
      
      Phone Number: 617-732-5241
    - Principal Investigator:
      
      Melanie Maytin, M.D.
  - Boston, Massachusetts, United States, 02114-2621
    - Not yet recruiting
    - Massachusetts General Hospital
    - Contact:
      
      Study Coordinator
      
      Phone Number: 617-726-5093
- Michigan
  - Lansing, Michigan, United States, 48912
    - Recruiting
    - Sparrow Clinical Research Institute
    - Contact:
      
      Study Coordinator
      
      Phone Number: 517-364-5732
    - Principal Investigator:
      
      John Ip, M.D.
  - Marquette, Michigan, United States, 49855-2705
    - Not yet recruiting
    - UP Health System - Marquette
    - Contact:
      
      Study Coordinator
      
      Phone Number: 906-449-3440
  - Ypsilanti, Michigan, United States, 48197-8633
    - Recruiting
    - Michigan Heart
    - Contact:
      
      Study Coordinator
      
      Phone Number: 734-712-8252
    - Principal Investigator:
      
      Jihn Han, M.D.
- Minnesota
  - Robbinsdale, Minnesota, United States, 55422
    - Not yet recruiting
    - North Memorial Heart and Vascular Institute
    - Contact:
      
      Study Coordinator
      
      Phone Number: 763-581-6714
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Mayo Clinic
    - Contact:
      
      Study Coordinator
      
      Phone Number: 507-284-2511
    - Principal Investigator:
      
      Abhishek Deshmukh, M.D.
- Missouri
  - Columbia, Missouri, United States, 65201-8023
    - Recruiting
    - Missouri Cardiovascular Specialists
    - Contact:
      
      Study Coordinator
      
      Phone Number: 573-256-3094
    - Principal Investigator:
      
      Daniel Pierce, M.D.
  - Columbia, Missouri, United States, 65212
    - Recruiting
    - University Hospital of Missouri
    - Contact:
      
      Study Coordinator
      
      Phone Number: 573-884-4099
    - Principal Investigator:
      
      Richard Weachter, M.D.
  - Kansas City, Missouri, United States, 64111-5934
    - Recruiting
    - Saint Lukes Health System
    - Contact:
      
      Study Coordinator
      
      Phone Number: 816-932-6275
    - Principal Investigator:
      
      Brian Ramza, M.D.
  - Saint Louis, Missouri, United States, 63110-1010
    - Recruiting
    - Washington University School of Medicine
    - Contact:
      
      Study Coordinator
      
      Phone Number: 314-454-7422
    - Principal Investigator:
      
      Mitchell Faddis, M.D.
- Nebraska
  - Omaha, Nebraska, United States, 68105
    - Recruiting
    - Nebraska Medicine
    - Contact:
      
      Study Coordinator
      
      Phone Number: 402-559-8862
    - Principal Investigator:
      
      Shane Tsai, M.D.
- New Jersey
  - Eatontown, New Jersey, United States, 07724
    - Recruiting
    - Monmouth Cardiology Associates
    - Contact:
      
      Study Coordinator
      
      Phone Number: 732-663-0300
    - Principal Investigator:
      
      L Steven Zukerman, M.D.
- New Mexico
  - Albuquerque, New Mexico, United States, 87106-4921
    - Recruiting
    - Presbyterian Heart Group
    - Contact:
      
      Study Coordinator
      
      Phone Number: 505-563-2716
    - Principal Investigator:
      
      Lawrence Nair, M.D.
- New York
  - Bay Shore, New York, United States, 11706
    - Recruiting
    - South Shore University Hospital
    - Contact:
      
      Site Coordinator
      
      Phone Number: 631-968-3009
    - Principal Investigator:
      
      Jonathan Willner, M.D.
  - Huntington, New York, United States, 11743
    - Recruiting
    - Huntington Hospital
    - Principal Investigator:
      
      Jonathan Willner, M.D.
    - Contact:
      
      Site Coordinator
      
      Phone Number: 631-547-7191
  - Manhasset, New York, United States, 11030
    - Recruiting
    - North Shore University Hospital
    - Contact:
      
      Site Coordinator
      
      Phone Number: 631-968-3009
    - Principal Investigator:
      
      Jonathan Willner, M.D.
  - Mount Kisco, New York, United States, 10549
    - Recruiting
    - Northern Westchester Hospital
    - Principal Investigator:
      
      Jonathan Willner, M.D.
    - Contact:
      
      Site Coordinator
      
      Phone Number: 914-362-6199
  - New Hyde Park, New York, United States, 11040
    - Recruiting
    - Long Island Jewish Medical Center
    - Principal Investigator:
      
      Jonathan Willner, M.D.
    - Contact:
      
      Site Coordinator
      
      Phone Number: 516-881-7027
  - New York, New York, United States, 10075
    - Recruiting
    - Lenox Hill Hospital
    - Principal Investigator:
      
      Jonathan Willner, M.D.
    - Contact:
      
      Site Coordinator
      
      Phone Number: 212-434-3934
  - New York, New York, United States, 10032
    - Recruiting
    - NewYork-Presbyterian/Columbia University Irving Medical Center
    - Contact:
      
      Study Coordinator
      
      Phone Number: 845-866-6426
    - Principal Investigator:
      
      Frederick Ehlert, M.D.
  - New York, New York, United States, 10021
    - Recruiting
    - New York-Presbyterian Hospital/Weill-Cornell Medical Center
    - Contact:
      
      Study Coordinator
      
      Phone Number: 212-746-4617
    - Principal Investigator:
      
      Steven Markowitz, M.D.
  - Poughkeepsie, New York, United States, 12601-3923
    - Recruiting
    - Hudson Valley Heart Center
    - Contact:
      
      Study Coordinator
      
      Phone Number: 51217 845-473-1188
    - Principal Investigator:
      
      Sankar Varanasi, M.D.
  - Staten Island, New York, United States, 10305
    - Recruiting
    - Staten Island University Hospital
    - Principal Investigator:
      
      Jonathan Willner, M.D.
    - Contact:
      
      Site Coordinator
      
      Phone Number: 718-226-7953
- North Carolina
  - Durham, North Carolina, United States, 27705
    - Not yet recruiting
    - Duke University Medical Center (DUMC)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 919-681-8983
  - Raleigh, North Carolina, United States, 27610
    - Recruiting
    - WakeMed Health & Hospitals
    - Contact:
      
      Study Coordinator
      
      Phone Number: 919-350-5252
    - Principal Investigator:
      
      Marc Silver, M.D.
- Ohio
  - Akron, Ohio, United States, 44304-1473
    - Recruiting
    - Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists
    - Contact:
      
      Study Coordinator
      
      Phone Number: 330-375-6673
    - Principal Investigator:
      
      Michael Pelini, M.D.
  - Cincinnati, Ohio, United States, 45219
    - Recruiting
    - The Christ Hospital Health Network
    - Contact:
      
      Study Coordinator
      
      Phone Number: 513-585-2159
    - Principal Investigator:
      
      Dean Kereiakes, M.D.
  - Cincinnati, Ohio, United States, 45267-0542
    - Not yet recruiting
    - University of Cincinnati
    - Contact:
      
      Study Coordinator
      
      Phone Number: 513-558-3415
  - Cleveland, Ohio, United States, 44195-0001
    - Not yet recruiting
    - Cleveland Clinic
    - Contact:
      
      Study Coordinator
      
      Phone Number: 216-444-4959
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18015
    - Recruiting
    - St Lukes University Health Network
    - Contact:
      
      Study Coordinator
      
      Phone Number: 484-526-7827
    - Principal Investigator:
      
      Darren Traub, M.D.
  - Danville, Pennsylvania, United States, 17822
    - Not yet recruiting
    - Geisinger Medical Center
    - Contact:
      
      Study Coordinator
      
      Phone Number: 570-214-4964
  - Erie, Pennsylvania, United States, 16507-1579
    - Not yet recruiting
    - UPMC Heart and Vascular Institute at UPMC Hamot
    - Contact:
      
      Study Coordinator
      
      Phone Number: 814-877-3395
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Not yet recruiting
    - Geisinger Wyoming Valley Medical Center
    - Contact:
      
      Study Coordinator
      
      Phone Number: 570-808-6123
- Tennessee
  - Nashville, Tennessee, United States, 37205-2018
    - Recruiting
    - Saint Thomas Research Institute
    - Contact:
      
      Study Coordinator
      
      Phone Number: 615-222-3870
    - Principal Investigator:
      
      James Baker, M.D.
  - Nashville, Tennessee, United States, 37232-8802
    - Not yet recruiting
    - Vanderbilt University Medical Center
    - Contact:
      
      Study Coordinator
      
      Phone Number: 615-343-8647
- Texas
  - Austin, Texas, United States, 78705-1852
    - Recruiting
    - Texas Cardiac Arrhythmia Research Foundation
    - Contact:
      
      Study Coordinator
      
      Phone Number: 512-522-9410
    - Principal Investigator:
      
      Robert Canby, M.D.
  - Fort Worth, Texas, United States, 76104-2821
    - Recruiting
    - Consultants in Cardiology
    - Contact:
      
      Study Coordinator
      
      Phone Number: 817-250-1950
    - Principal Investigator:
      
      Theodore Takata, M.D.
  - Fort Worth, Texas, United States, 76104
    - Recruiting
    - Heart Center of North Texas
    - Contact:
      
      Study Coordinator
      
      Phone Number: 817-334-2800
    - Principal Investigator:
      
      Aleem Mughal, M.D.
  - The Woodlands, Texas, United States, 77384-4103
    - Not yet recruiting
    - EP Heart
    - Contact:
      
      Study Coordinator
      
      Phone Number: 713-486-1637
- Washington
  - Spokane, Washington, United States, 99204-2352
    - Not yet recruiting
    - Kootenai Heart Clinics Northwest
    - Contact:
      
      Study Coordinator
      
      Phone Number: 509-847-2500
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53215
    - Recruiting
    - Aurora Cardiovascular Services
    - Contact:
      
      Study Coordinator
      
      Phone Number: 262-249-5432
    - Principal Investigator:
      
      Jodi Lyn Zilinski, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	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

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of HF hospitalization or HF related deaths Time Frame: Up to 5 years	Summarize the number of HF hospitalization or HF related deaths that were not preceded by a High-Risk Status.	Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

July 27, 2020

First Posted (Actual)

July 28, 2020

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

HFRS PAS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Heart Failure

Clinical Trials on Observational

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