Summary

at San Francisco, California and other locations
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

  • University of California San Francisco UCSF Medical Center
    San Francisco, California, 94143-0138, United States
  • Baylor Research Institute (Fort Worth TX)
    Fort Worth, Texas, 76104-4110, United States
  • Baylor Research Institute (Plano TX)
    Plano, Texas, 75093-3691, United States
  • Baylor Research Institute (Dallas-TX)
    Dallas, Texas, 75206, United States
  • Texas Cardiac Arrhythmia Research Foundation
    Austin, Texas, 78705, United States
  • Saint Lukes Health System
    Kansas City, Missouri, 64111-3220, United States
  • Iowa Heart Center
    Des Moines, Iowa, 50314, United States
  • Washington University School of Medicine
    Saint Louis, Missouri, 63110, United States
  • Aurora Cardiovascular Services
    Milwaukee, Wisconsin, 53215, United States
  • Ochsner Clinic Foundation
    New Orleans, Louisiana, 70121-2429, United States
  • The Christ Hospital
    Cincinnati, Ohio, 45219, United States
  • Cleveland Clinic
    Cleveland, Ohio, 44195, United States
  • Jacksonville Heart (Baptist Medical)
    Jacksonville, Florida, 32207, United States
  • Bay Heart Group
    Tampa, Florida, 33607, United States
  • Washington Adventist Hospital
    Takoma Park, Maryland, 20912-6367, United States
  • Geisinger Medical Center
    Danville, Pennsylvania, 17822, United States
  • Lehigh Valley Health Network
    Allentown, Pennsylvania, 18103, United States
  • The Valley Hospital
    Ridgewood, New Jersey, 07450, United States
  • NYU Langone Medical Center
    New York, New York, 10016-4303, United States
  • National Kyushu Medical Center
    Fukuoka City, 810-8563, Japan
  • Saitama Medical University International Medical Center
    Hidaka, 350-1298, Japan
  • Hirosaki University Hospital
    Hirosaki, 036-8563, Japan
  • Hospital of the University of Occupational and Environmental Health
    Kitakyushu City, 807-8556, Japan
  • Saiseikai Kumamoto Hospital
    Kumamoto, 861-4193, Japan
  • Kyorin University Hospital
    Mitaka, 181-8611, Japan
  • Iwate Medical University Hospital
    Morioka, 020-8505, Japan
  • Ogaki Municipal Hospital
    Ogaki City, 503-8502, Japan
  • Okayama University Hospital
    Okayama city, 700-8558, Japan
  • Showa University Hospital
    Shinagawa-Ku, 142-8555, Japan
  • National Cerebral and Cardiovascular Center
    Suita, 565-8565, Japan
  • The Jikei University School of Medicine Hospital
    Tokyo, 105-8471, Japan
  • Toho University Omori Medical Center
    Tokyo, 143-8541, Japan
  • Fujita Health University Hospital
    Toyoake, 470-1192, Japan
  • Catharina Ziekenhuis
    Eindhoven, Netherlands
  • Maastricht Universitair Medisch Centrum (MUMC)
    Maastricht, Netherlands
  • Ziekenhuis Oost Limburg - Campus St.-Jan
    Leuven, Belgium
  • Centro Hospitalar Lisboa Ocidental - Hospital de Santa Cruz
    Carnaxide, Portugal
  • Hospital Senhora da Oliveira, Guimaraes
    Guimarães, Portugal
  • Centro Hospitarlar Lisboa Norte - Hospital de Santa Maria
    Lisboa, Portugal
  • Hospital do Espirito Santo
    Ponta Delgada, Portugal
  • Centro Hospitalar do Porto - Hospital de Santo Antonio
    Porto, Portugal
  • Hospital Distrital de Santarem
    Santarém, Portugal
  • Ospedale classificato ed equiparato Sacro Cuore
    Negrar, Italy
  • Presidio Ospedaliero Santa Maria del Carmine
    Rovereto, 38068, Italy
  • Evaggelismos Hospital
    Athens, 10676, Greece
  • The Chaim Sheba Medical Center
    Tel HaShomer, 52621, Israel
  • King Fahd Armed Forces Hospital
    Jeddah, 21159, Saudi Arabia
  • Prince Sultan Cardiac Center
    Riyadh, Saudi Arabia

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
ID
NCT02746471
Study Type
Observational
Last Updated
March 28, 2018