Reveal LINQ Registry

Medtronic Reveal LINQ Insertable Cardiac Monitor Registry

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

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac
• Intervention / Treatment: Device: Reveal LINQ

Detailed Description

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 36 months.

• Study Type: Observational
• Enrollment (Actual): 1604

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients intended to receive a market-released Reveal LINQ device are eligible to enroll in the Registry. All enrolled patients that have an attempted procedure will be included in the analysis. Consented patients who failed to receive a Reveal LINQ device may be exited from the registry when all reportable events are resolved.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature	Clinical actions taken over the course of study follow-up	Implant to 36 months post-implant
Number of Participants With Procedure-related Acute Infection Rate	Acute infection rate in the subjects who were followed for at least 30 days or had an infection prior to 30 days. Infections are as assessed by the Investigator and defined as deep incision site or superficial infection. Deep incision site are classified as pain, redness, or drainage at incision site requiring the device to be removed or IV antibiotics administered. Superficial infections are defined as redness beyond procedure expectation and oral antibiotics administered. For both deep incision and superficial infections, a physician directed intervention must occur for the event to be defined as an infection.	Implant to 30 days post-implant

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: Suneet Mittal, M.D., The Valley Hospital

Publications and helpful links

General Publications

• Beinart SC, Natale A, Verma A, Amin A, Kasner S, Diener HC, Del Greco M, Wilkoff BL, Pouliot E, Franco N, Mittal S. Real-world comparison of in-hospital Reveal LINQ insertable cardiac monitor insertion inside and outside of the cardiac catheterization or electrophysiology laboratory. Am Heart J. 2019 Jan;207:76-82. doi: 10.1016/j.ahj.2018.10.002. Epub 2018 Oct 14.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): June 4, 2021
• Study Completion (Actual): June 4, 2021

Study Registration Dates

• First Submitted: February 29, 2016
• First Submitted That Met QC Criteria: April 18, 2016
• First Posted (Estimate): April 21, 2016

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: Reveal LINQ Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No