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Summary

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

  • Baylor Research Institute (Fort Worth TX) in progress, not accepting new patients
    Fort Worth, Texas, 76104-4110, United States
  • Baylor Research Institute (Plano TX) in progress, not accepting new patients
    Plano, Texas, 75093-3691, United States
  • Baylor Health Care System in progress, not accepting new patients
    Dallas, Texas, 75246-2017, United States
  • Texas Cardiac Arrhythmia Research Foundation in progress, not accepting new patients
    Austin, Texas, 78705, United States
  • Saint Lukes Health System in progress, not accepting new patients
    Kansas City, Missouri, 64111-3220, United States
  • Iowa Heart Center in progress, not accepting new patients
    West Des Moines, Iowa, 50266-8209, United States
  • Washington University School of Medicine in progress, not accepting new patients
    St. Louis, Missouri, 63110, United States
  • Aurora Cardiovascular Services in progress, not accepting new patients
    Milkwaukee, Wisconsin, 53215, United States
  • Ochsner Clinic Foundation in progress, not accepting new patients
    New Orleans, Louisiana, 70121-2429, United States
  • The Christ Hospital in progress, not accepting new patients
    Cincinnati, Ohio, 45219, United States
  • Cleveland Clinic in progress, not accepting new patients
    Cleveland, Ohio, 44195, United States
  • University of Pittsburgh Medical Center withdrawn
    Pittsburgh, Pennsylvania, 15213, United States
  • Baptist Heart Specialists in progress, not accepting new patients
    Jacksonville, Florida, 32207, United States
  • Bay Heart Group in progress, not accepting new patients
    Tampa, Florida, 33614, United States
  • Washington Adventist Hospital in progress, not accepting new patients
    Takoma Park, Maryland, 20912-6367, United States
  • Geisinger Medical Center terminated
    Danville, Pennsylvania, 17822, United States
  • Lehigh Valley Health Network in progress, not accepting new patients
    Allentown, Pennsylvania, 18103, United States
  • The Valley Hospital in progress, not accepting new patients
    Ridgewood, New Jersey, 07450, United States
  • NYU Langone Medical Center in progress, not accepting new patients
    New York, New York, 10016-4303, United States
  • Brigham & Women's Hospital terminated
    Boston, Massachusetts, 02115, United States
  • The James Cook University Hospital - South Tees Hospitals NHS in progress, not accepting new patients
    Middlesbrough, United Kingdom
  • 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
  • Ziekenhuis Oost Limburg - Campus St.-Jan in progress, not accepting new patients
    Leuven, Belgium
  • Universitätsklinikum Essen in progress, not accepting new patients
    Essen, Germany
  • 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
  • Semmelweis Egyetem AOK withdrawn
    Budapest, 1122, Hungary
  • 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
  • Evaggelismos Hospital in progress, not accepting new patients
    Athens, 10676, Greece
  • Gennimatas General Hospital in progress, not accepting new patients
    Athens, 11527, Greece
  • The Chaim Sheba Medical Center in progress, not accepting new patients
    Tel HaShomer, 52621, Israel
  • 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

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 1, 2017