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Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

The Reveal LINQ Registry will generate reliable long-term "real world" data of product performance, economic valuation, site-of-service procedural information.

Official Title

Medtronic Reveal LINQ Insertable Cardiac Monitor Registry

Details

The study is a prospective, non-randomized, observational, multi-center, global study. The study will characterize clinical actions initiated by Reveal LINQ arrhythmia detection and estimate procedure-related acute infection rate. Approximately 1,500 subjects will be implanted with a Reveal LINQ ICM and undergo continuous remote monitoring and be followed prospectively from insertion through 18 months.

Keywords

Arrhythmias, Cardiac

Eligibility

You can join if…

  • Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements.
  • Subject is intended to receive or be treated with the have a Reveal LINQ ICM inserted in the next 30 days.
  • Patient enrolled before or on the same date of insertion of the Reveal LINQ ICM
  • Subject consent prior to ICM insertion

You CAN'T join if...

  • Subject who is, or is expected to be inaccessible for follow-up
  • Subject with exclusion criteria required by local law
  • Subject is currently enrolled in or plans to enroll a concurrent study that may confound the results of this study. Co-enrollment in any concurrent drug and/or device clinical study (including registries) requires approval of the study manager or designee.

Locations

  • Baptist Heart Specialists in progress, not accepting new patients
    Jacksonville, Florida, 32207, USA
  • Bay Heart Group in progress, not accepting new patients
    Tampa, Florida, 33614, USA
  • Iowa Heart Center in progress, not accepting new patients
    West Des Moines, Iowa, 50266, USA
  • Ochsner Clinic Foundation in progress, not accepting new patients
    New Orleans, Louisiana, 70121, USA
  • Washington Adventist Hospital in progress, not accepting new patients
    Takoma Park, Maryland, 20912, USA
  • Brigham & Women's Hospital terminated
    Boston, Massachusetts, 02115, USA
  • Saint Lukes Health System in progress, not accepting new patients
    Kansas City, Missouri, 64111, USA
  • Washington University School of Medicine in progress, not accepting new patients
    St. Louis, Missouri, 63110, USA
  • The Valley Hospital in progress, not accepting new patients
    Ridgewood, New Jersey, 07450, USA
  • NYU Langone Medical Center in progress, not accepting new patients
    New York, New York, 10016, USA
  • The Christ Hospital in progress, not accepting new patients
    Cincinnati, Ohio, 45219, USA
  • Cleveland Clinic in progress, not accepting new patients
    Cleveland, Ohio, 44195, USA
  • Lehigh Valley Health Network in progress, not accepting new patients
    Allentown, Pennsylvania, 18103, USA
  • Geisinger Medical Center terminated
    Danville, Pennsylvania, 17822, USA
  • University of Pittsburgh Medical Center withdrawn
    Pittsburgh, Pennsylvania, 15213, USA
  • Texas Cardiac Arrhythmia Research Foundation in progress, not accepting new patients
    Austin, Texas, 78705, USA
  • Baylor Health Care System in progress, not accepting new patients
    Dallas, Texas, 75246, USA
  • Baylor Research Institute (Fort Worth TX) in progress, not accepting new patients
    Fort Worth, Texas, 76104, USA
  • Baylor Research Institute (Plano TX) in progress, not accepting new patients
    Plano, Texas, 75093, USA
  • Aurora Cardiovascular Services in progress, not accepting new patients
    Milkwaukee, Wisconsin, 53215, USA
  • Ziekenhuis Oost Limburg - Campus St.-Jan in progress, not accepting new patients
    Leuven, Belgium
  • Universitätsklinikum Essen in progress, not accepting new patients
    Essen, Germany
  • Evaggelismos Hospital in progress, not accepting new patients
    Athens, 10676, Greece
  • Gennimatas General Hospital in progress, not accepting new patients
    Athens, 11527, Greece
  • Semmelweis Egyetem AOK withdrawn
    Budapest, 1122, Hungary
  • The Chaim Sheba Medical Center in progress, not accepting new patients
    Tel HaShomer, 52621, Israel
  • Ospedale classificato ed equiparato Sacro Cuore in progress, not accepting new patients
    Negrar, Italy
  • Presidio Ospedaliero Santa Maria del Carmine in progress, not accepting new patients
    Rovereto, 38068, Italy
  • Azienda Ospedaliera Universitaria Ospedali Riuniti San Giovanni di Dio e Ruggi d'Aragona in progress, not accepting new patients
    Salerno, 81431, Italy
  • National Kyushu Medical Center accepting new patients
    Fukuoka City, 810-8563, Japan
  • Saitama Medical University International Medical Center accepting new patients
    Hidaka, 350-1298, Japan
  • Hirosaki University Hospital accepting new patients
    Hirosaki, 036-8563, Japan
  • Hospital of the University of Occupational and Environmental Health accepting new patients
    Kita-kyushu City, 807-8556, Japan
  • Saiseikai Kumamoto Hospital accepting new patients
    Kumamoto, 861-4193, Japan
  • Kyorin University Hospital accepting new patients
    Mitaka, 181-8611, Japan
  • Iwate Medical University Hospital accepting new patients
    Morioka, 020-8505, Japan
  • Ogaki Municipal Hospital accepting new patients
    Ogaki City, 503-8502, Japan
  • Okayama University Hospital accepting new patients
    Okayama city, 700-8558, Japan
  • Showa University Hospital accepting new patients
    Shinagawa-Ku, 142-8555, Japan
  • National Cerebral and Cardiovascular Center accepting new patients
    Suita, 565-8565, Japan
  • The Jikei University School of Medicine Hospital accepting new patients
    Tokyo, 105-8471, Japan
  • Toho University Omori Medical Center accepting new patients
    Tokyo, 143-8541, Japan
  • Fujita Health University Hospital accepting new patients
    Toyoake, 470-1192, Japan
  • Catharina Ziekenhuis in progress, not accepting new patients
    Eindhoven, Netherlands
  • Maastricht Universitair Medisch Centrum (MUMC) in progress, not accepting new patients
    Maastricht, Netherlands
  • King Fahd Armed Forces Hospital in progress, not accepting new patients
    Jeddah, 21159, Saudi Arabia
  • Prince Sultan Cardiac Center in progress, not accepting new patients
    Riyadh, Saudi Arabia
  • Hospital Clínico Universitario Virgen de la Arrixaca in progress, not accepting new patients
    El Palmar, 30120, Spain
  • Hospital Universitario Puerta de Hierro Majadahonda in progress, not accepting new patients
    Majadahonda, 28222, Spain
  • The James Cook University Hospital - South Tees Hospitals NHS in progress, not accepting new patients
    Middlesbrough, United Kingdom

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
ID
NCT02746471
Study Type
Observational
Last Updated
March 2017