FDA-Mandated study tracks heart device safety in real patients
NCT ID NCT04024943
Summary
This study is monitoring the long-term safety and performance of a specific heart device lead (Model 4798) in over 1,000 patients with heart failure. It's a required follow-up study by the FDA after the device's initial approval. Researchers are tracking patients for five years to see how well the lead works and if any problems occur in everyday use.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes NO responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Locations
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Alaska Heart
Anchorage, Alaska, 99508-4673, United States
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Associates in Cardiology PA
Silver Spring, Maryland, 20910-1265, United States
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Athens Medical Center
Marousi, 15125, Greece
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Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215, United States
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Azienda Ospedaliera Ospedale Niguarda Ca Granda
Milan, 20162, Italy
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Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"
Castrovillari, 87012, Italy
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Azienda ospedaleria Santa Maria della Misericordia di Udine
Udine, Italy
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Baptist Health
Jacksonville, Florida, 32207, United States
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Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital
Blackpool, United Kingdom
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Brigham & Women's Hospital (Boston, MA)
Boston, Massachusetts, 02115-6110, United States
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CHRU Brest - Hôpital de la Cavale Blanche
Brest, 29609, France
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CHRU La Rochelle
La Rochelle, 17019, France
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CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol
Caen, 14033, France
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CHU de Clermont Ferrand
Clermont-Ferrand, 63003, France
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CHU de Dijon - Hospital Le Bocage
Dijon, 21079, France
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COR Healthcare
Torrance, California, 90505, United States
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Capio - Clinique du Tonkin
Villeurbanne, 69100, France
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Cardiology Associates Medical Group
Ventura, California, 93003, United States
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Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas, 72410-4163, United States
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Cardiopark Zurich
Zurich, 8027, Switzerland
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Cardiovascular Consultants Medical Group (Van Nuys)
Van Nuys, California, 91405-3646, United States
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Cardiovascular Institute of Northwest Florida
Panama City, Florida, 32405, United States
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Central Manchester University Hospitals NHS - Manchester Royal Infirmary
Manchester, United Kingdom
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Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord
Saint-Priest-en-Jarez, 42270, France
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Centre Hospitalier de la Côte Basque
Bayonne, 64109, France
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Centre hospitalier de la région d'Annecy
Pringy, 74374, France
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Centro Hospitalar Universitário de São João
Porto, 4200-319, Portugal
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Chula Vista Cardiac Center
Chula Vista, California, 91910, United States
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Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756-3356, United States
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Clinique Rhône Durance
Avignon, 84082, France
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Colorado Heart and Vascular
Lakewood, Colorado, 80228, United States
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Colorado Springs Cardiology
Colorado Springs, Colorado, 80907, United States
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Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, 15706, Spain
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Complejo Universitario de Salamanca
Salamanca, 37007, Spain
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Consultants in Cardiology
Fort Worth, Texas, 76104-2821, United States
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Deaconess Specialty Physicians
Evansville, Indiana, 47710, United States
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Denver Heart
Denver, Colorado, 80220-3918, United States
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Duke University Medical Center (DUMC)
Durham, North Carolina, 27705, United States
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EP Heart
The Woodlands, Texas, 77384, United States
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Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
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Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
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Générale de Santé - Hôpital Privé Saint Martin
Caen, 14000, France
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Hartford Hospital
Hartford, Connecticut, 06102, United States
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Heart & Vascular Institute of Florida
Safety Harbor, Florida, 34695-6604, United States
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Heart Center of North Texas
Fort Worth, Texas, 761014, United States
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Heart Rhythm Consultants P.A. (Sarasota Memorial Research)
Sarasota, Florida, 34233, United States
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Heart Rhythm Solutions
Hollywood, Florida, 33021, United States
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Hopital prive Clairval - Ramsay Sante
Marseille, 13009, France
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Hospital Clínico Universitario de Valladolid
Valladolid, 47006, Spain
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Hospital Distrital de Santarém
Santarém, 2000-177, Portugal
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Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
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Hospital Universitario Clínico San Cecilio
Granada, Spain
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Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, 38010, Spain
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Hospital Universitario Virgen de las Nieves
Granada, 18014, Spain
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Hospital Universitario da Coruna
A Coruña, 15006, Spain
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Hospital da Senhora da Oliveira - Guimarães
Guimarães, 4835-044, Portugal
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Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
Lisbon, 1649-035, Portugal
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Hudson Valley Heart Center
Poughkeepsie, New York, 12601-3923, United States
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Huntington Hospital
Huntington, New York, 11743, United States
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Hygeia Hospital
Athens, 15123, Greece
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Hôpitaux Universitaires de Genève
Geneva, 1205, Switzerland
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Imperial College Healthcare NHS Trust - Hammersmith Hospital
London, United Kingdom
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Iowa Heart Center
West Des Moines, Iowa, 50266, United States
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Kansas University Medical Center
Kansas City, Kansas, 66160-8500, United States
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Kootenai Heart Clinics Northwest
Spokane, Washington, 99204-2352, United States
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Lenox Hill Hospital
New York, New York, 10075, United States
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Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, United Kingdom
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Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114-2621, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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MedStar Health Research Institute
Baltimore, Maryland, 21237-3958, United States
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Michigan Heart
Ypsilanti, Michigan, 48197-8633, United States
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Missouri Cardiovascular Specialists
Columbia, Missouri, 65201-8023, United States
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Monmouth Cardiology Associates
Ocean City, New Jersey, 07712-4762, United States
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Nebraska Medicine
Omaha, Nebraska, 68105, United States
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New York-Presbyterian Hospital/Columbia University Medical Center
New York, New York, 10032, United States
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New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10021, United States
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North Memorial Heart and Vascular Institute
Robbinsdale, Minnesota, 55422, United States
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North Shore University Hospital
Manhasset, New York, 11030, United States
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Northern Westchester Hospital
Mount Kisco, New York, 10549, United States
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Norton Heart Specialists
Louisville, Kentucky, 40205-3373, United States
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Nouvelles Cliniques Nantaises
Nantes, France
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Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)
Bratislava, Slovakia
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Ospedale "Vito Fazzi" Lecce
Lecce, 73100, Italy
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Our Lady of the Lake Office of Research
Baton Rouge, Louisiana, 70808, United States
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Phoebe Putney Memorial Hospital
Albany, Georgia, 31701-1943, United States
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Policlinico Sant' Orsola - Malpighi
Bologna, 40138, Italy
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Presbyterian Heart Group
Albuquerque, New Mexico, 87106-4921, United States
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Presidio Ospedaliero Centrale - SS. Annunziata
Taranto, 74024, Italy
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Saint Elizabeth Healthcare
Edgewood, Kentucky, 41017, United States
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Saint Lukes Health System
Kansas City, Missouri, 64111-5934, United States
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Saint Thomas Research Institute
Nashville, Tennessee, 37205-2018, United States
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Saint Vincent Heart Clinic Arkansas
Little Rock, Arkansas, 72205-6202, United States
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San Diego Arrhythmia Associates
San Diego, California, 92103, United States
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Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General
Sheffield, United Kingdom
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South Shore University Hospital
Bay Shore, New York, 11706, United States
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Southwest EP
Chandler, Arizona, 85295-1680, United States
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Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
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St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015-1155, United States
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Staten Island University Hospital
Staten Island, New York, 10305-3436, United States
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Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists
Akron, Ohio, 44304-1473, United States
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Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705-1852, United States
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The Christ Hospital Health Network
Cincinnati, Ohio, 45219, United States
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The James Cook University Hospital - South Tees Hospitals NHS
Middlesbrough, United Kingdom
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Tidal Health Peninsula Regional
Salisbury, Maryland, 21804-6938, United States
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UP Health System - Marquette
Marquette, Michigan, 49855-2705, United States
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UPMC Heart and Vascular Institute at UPMC Hamot
Erie, Pennsylvania, 16507-1579, United States
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University Hospital of Missouri
Columbia, Missouri, 65212, United States
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University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
Birmingham, United Kingdom
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University of Cincinnati
Cincinnati, Ohio, 45267-0542, United States
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Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8802, United States
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WakeMed Health & Hospitals
Raleigh, North Carolina, 27610, United States
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Washington University
St Louis, Missouri, 63110-1010, United States
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Yale New Haven Hospital
New Haven, Connecticut, 06520-8017, United States
Conditions
Explore the condition pages connected to this study.