Reveal LINQ Registry

NCT ID: NCT02746471

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1604 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2021-06-04

Brief Summary

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

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.

Conditions

Arrhythmias, Cardiac

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Reveal LINQ

Intervention Type: DEVICE

Eligibility Criteria

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 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suneet Mittal, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Valley Hospital

Locations

University of California San Francisco UCSF Medical Center

San Francisco, California, United States

Jacksonville Heart (Baptist Medical)

Jacksonville, Florida, United States

Bay Heart Group

Tampa, Florida, United States

Iowa Heart Center

Des Moines, Iowa, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Washington Adventist Hospital

Takoma Park, Maryland, United States

Saint Lukes Health System

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

The Valley Hospital

Ridgewood, New Jersey, United States

NYU Langone Medical Center

New York, New York, United States

The Christ Hospital

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Baylor Research Institute (Dallas-TX)

Dallas, Texas, United States

Baylor Research Institute (Fort Worth TX)

Fort Worth, Texas, United States

Baylor Research Institute (Plano TX)

Plano, Texas, United States

Aurora Cardiovascular Services

Milwaukee, Wisconsin, United States

Ziekenhuis Oost Limburg - Campus St.-Jan

Leuven, , Belgium

Evaggelismos Hospital

Athens, , Greece

The Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Ospedale classificato ed equiparato Sacro Cuore

Negrar, , Italy

Presidio Ospedaliero Santa Maria del Carmine

Rovereto, , Italy

National Kyushu Medical Center

Fukuoka, , Japan

Saitama Medical University International Medical Center

Hidaka, , Japan

Hirosaki University Hospital

Hirosaki, , Japan

Hospital of the University of Occupational and Environmental Health

Kitakyushu, , Japan

Saiseikai Kumamoto Hospital

Kumamoto, , Japan

Kyorin University Hospital

Mitaka, , Japan

Iwate Medical University Hospital

Morioka, , Japan

Okayama University Hospital

Okayama, , Japan

Ogaki Municipal Hospital

Ōgaki, , Japan

Showa University Hospital

Shinagawa-Ku, , Japan

National Cerebral and Cardiovascular Center

Suita, , Japan

The Jikei University School of Medicine Hospital

Tokyo, , Japan

Toho University Omori Medical Center

Tokyo, , Japan

Fujita Health University Hospital

Toyoake, , Japan

Catharina Ziekenhuis

Eindhoven, , Netherlands

Maastricht Universitair Medisch Centrum (MUMC)

Maastricht, , Netherlands

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

Lisbon, , Portugal

Hospital do Espirito Santo

Ponta Delgada, , Portugal

Centro Hospitalar do Porto - Hospital de Santo Antonio

Porto, , Portugal

Hospital Distrital de Santarem

Santarém, , Portugal

King Fahd Armed Forces Hospital

Jeddah, , Saudi Arabia

Prince Sultan Cardiac Center

Riyadh, , Saudi Arabia

Countries

United States; Belgium; Greece; Israel; Italy; Japan; Netherlands; Portugal; Saudi Arabia

References

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.

Reference Type: DERIVED

PMID: 30487072 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Reveal LINQ Registry

Identifier Type: -

Identifier Source: org_study_id