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

Locations

  • Alaska Heart

    Anchorage, Alaska, 99508-4673, United States

  • Associates in Cardiology PA

    Silver Spring, Maryland, 20910-1265, United States

  • Athens Medical Center

    Marousi, 15125, Greece

  • Aurora Cardiovascular Services

    Milwaukee, Wisconsin, 53215, United States

  • Azienda Ospedaliera Ospedale Niguarda Ca Granda

    Milan, 20162, Italy

  • Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"

    Castrovillari, 87012, Italy

  • Azienda ospedaleria Santa Maria della Misericordia di Udine

    Udine, Italy

  • Baptist Health

    Jacksonville, Florida, 32207, United States

  • Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital

    Blackpool, United Kingdom

  • Brigham & Women's Hospital (Boston, MA)

    Boston, Massachusetts, 02115-6110, United States

  • CHRU Brest - Hôpital de la Cavale Blanche

    Brest, 29609, France

  • CHRU La Rochelle

    La Rochelle, 17019, France

  • CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol

    Caen, 14033, France

  • CHU de Clermont Ferrand

    Clermont-Ferrand, 63003, France

  • CHU de Dijon - Hospital Le Bocage

    Dijon, 21079, France

  • COR Healthcare

    Torrance, California, 90505, United States

  • Capio - Clinique du Tonkin

    Villeurbanne, 69100, France

  • Cardiology Associates Medical Group

    Ventura, California, 93003, United States

  • Cardiology Associates of Northeast Arkansas

    Jonesboro, Arkansas, 72410-4163, United States

  • Cardiopark Zurich

    Zurich, 8027, Switzerland

  • Cardiovascular Consultants Medical Group (Van Nuys)

    Van Nuys, California, 91405-3646, United States

  • Cardiovascular Institute of Northwest Florida

    Panama City, Florida, 32405, United States

  • Central Manchester University Hospitals NHS - Manchester Royal Infirmary

    Manchester, United Kingdom

  • Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord

    Saint-Priest-en-Jarez, 42270, France

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64109, France

  • Centre hospitalier de la région d'Annecy

    Pringy, 74374, France

  • Centro Hospitalar Universitário de São João

    Porto, 4200-319, Portugal

  • Chula Vista Cardiac Center

    Chula Vista, California, 91910, United States

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida, 33756-3356, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinique Rhône Durance

    Avignon, 84082, France

  • Colorado Heart and Vascular

    Lakewood, Colorado, 80228, United States

  • Colorado Springs Cardiology

    Colorado Springs, Colorado, 80907, United States

  • Complejo Hospitalario Universitario de Santiago de Compostela

    Santiago de Compostela, 15706, Spain

  • Complejo Universitario de Salamanca

    Salamanca, 37007, Spain

  • Consultants in Cardiology

    Fort Worth, Texas, 76104-2821, United States

  • Deaconess Specialty Physicians

    Evansville, Indiana, 47710, United States

  • Denver Heart

    Denver, Colorado, 80220-3918, United States

  • Duke University Medical Center (DUMC)

    Durham, North Carolina, 27705, United States

  • EP Heart

    The Woodlands, Texas, 77384, United States

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711, United States

  • Générale de Santé - Hôpital Privé Saint Martin

    Caen, 14000, France

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Heart & Vascular Institute of Florida

    Safety Harbor, Florida, 34695-6604, United States

  • Heart Center of North Texas

    Fort Worth, Texas, 761014, United States

  • Heart Rhythm Consultants P.A. (Sarasota Memorial Research)

    Sarasota, Florida, 34233, United States

  • Heart Rhythm Solutions

    Hollywood, Florida, 33021, United States

  • Hopital prive Clairval - Ramsay Sante

    Marseille, 13009, France

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47006, Spain

  • Hospital Distrital de Santarém

    Santarém, 2000-177, Portugal

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Clínico San Cecilio

    Granada, Spain

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, 38010, Spain

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014, Spain

  • Hospital Universitario da Coruna

    A Coruña, 15006, Spain

  • Hospital da Senhora da Oliveira - Guimarães

    Guimarães, 4835-044, Portugal

  • Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE

    Lisbon, 1649-035, Portugal

  • Hudson Valley Heart Center

    Poughkeepsie, New York, 12601-3923, United States

  • Huntington Hospital

    Huntington, New York, 11743, United States

  • Hygeia Hospital

    Athens, 15123, Greece

  • Hôpitaux Universitaires de Genève

    Geneva, 1205, Switzerland

  • Imperial College Healthcare NHS Trust - Hammersmith Hospital

    London, United Kingdom

  • Iowa Heart Center

    West Des Moines, Iowa, 50266, United States

  • Kansas University Medical Center

    Kansas City, Kansas, 66160-8500, United States

  • Kootenai Heart Clinics Northwest

    Spokane, Washington, 99204-2352, United States

  • Lenox Hill Hospital

    New York, New York, 10075, United States

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool, United Kingdom

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114-2621, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • MedStar Health Research Institute

    Baltimore, Maryland, 21237-3958, United States

  • Michigan Heart

    Ypsilanti, Michigan, 48197-8633, United States

  • Missouri Cardiovascular Specialists

    Columbia, Missouri, 65201-8023, United States

  • Monmouth Cardiology Associates

    Ocean City, New Jersey, 07712-4762, United States

  • Nebraska Medicine

    Omaha, Nebraska, 68105, United States

  • New York-Presbyterian Hospital/Columbia University Medical Center

    New York, New York, 10032, United States

  • New York-Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York, 10021, United States

  • North Memorial Heart and Vascular Institute

    Robbinsdale, Minnesota, 55422, United States

  • North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549, United States

  • Norton Heart Specialists

    Louisville, Kentucky, 40205-3373, United States

  • Nouvelles Cliniques Nantaises

    Nantes, France

  • Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)

    Bratislava, Slovakia

  • Ospedale "Vito Fazzi" Lecce

    Lecce, 73100, Italy

  • Our Lady of the Lake Office of Research

    Baton Rouge, Louisiana, 70808, United States

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701-1943, United States

  • Policlinico Sant' Orsola - Malpighi

    Bologna, 40138, Italy

  • Presbyterian Heart Group

    Albuquerque, New Mexico, 87106-4921, United States

  • Presidio Ospedaliero Centrale - SS. Annunziata

    Taranto, 74024, Italy

  • Saint Elizabeth Healthcare

    Edgewood, Kentucky, 41017, United States

  • Saint Lukes Health System

    Kansas City, Missouri, 64111-5934, United States

  • Saint Thomas Research Institute

    Nashville, Tennessee, 37205-2018, United States

  • Saint Vincent Heart Clinic Arkansas

    Little Rock, Arkansas, 72205-6202, United States

  • San Diego Arrhythmia Associates

    San Diego, California, 92103, United States

  • Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General

    Sheffield, United Kingdom

  • South Shore University Hospital

    Bay Shore, New York, 11706, United States

  • Southwest EP

    Chandler, Arizona, 85295-1680, United States

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912, United States

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania, 18015-1155, United States

  • Staten Island University Hospital

    Staten Island, New York, 10305-3436, United States

  • Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists

    Akron, Ohio, 44304-1473, United States

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705-1852, United States

  • The Christ Hospital Health Network

    Cincinnati, Ohio, 45219, United States

  • The James Cook University Hospital - South Tees Hospitals NHS

    Middlesbrough, United Kingdom

  • Tidal Health Peninsula Regional

    Salisbury, Maryland, 21804-6938, United States

  • UP Health System - Marquette

    Marquette, Michigan, 49855-2705, United States

  • UPMC Heart and Vascular Institute at UPMC Hamot

    Erie, Pennsylvania, 16507-1579, United States

  • University Hospital of Missouri

    Columbia, Missouri, 65212, United States

  • University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

    Birmingham, United Kingdom

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0542, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-8802, United States

  • WakeMed Health & Hospitals

    Raleigh, North Carolina, 27610, United States

  • Washington University

    St Louis, Missouri, 63110-1010, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520-8017, United States

Conditions

Explore the condition pages connected to this study.