Reveal LINQ Registry

NCT02746471 | Completed Results

• 1 other identifier: Reveal LINQ Registry
• Study Type: observational
• Target: 1,604
• Locations: 9 countries
• Sites: 48

Brief Summary

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

Conditions

Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Reveal LINQ DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (48)

University of California San Francisco UCSF Medical Center

San Francisco, California, 94143-0138, United States

Location

Jacksonville Heart (Baptist Medical)

Jacksonville, Florida, 32207, United States

Location

Bay Heart Group

Tampa, Florida, 33607, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50314, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121-2429, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912-6367, United States

Location

Saint Lukes Health System

Kansas City, Missouri, 64111-3220, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

NYU Langone Medical Center

New York, New York, 10016-4303, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Baylor Research Institute (Dallas-TX)

Dallas, Texas, 75206, United States

Location

Baylor Research Institute (Fort Worth TX)

Fort Worth, Texas, 76104-4110, United States

Location

Baylor Research Institute (Plano TX)

Plano, Texas, 75093-3691, United States

Location

Aurora Cardiovascular Services

Milwaukee, Wisconsin, 53215, United States

Location

Ziekenhuis Oost Limburg - Campus St.-Jan

Leuven, Belgium

Location

Evaggelismos Hospital

Athens, 10676, Greece

Location

The Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Ospedale classificato ed equiparato Sacro Cuore

Negrar, Italy

Location

Presidio Ospedaliero Santa Maria del Carmine

Rovereto, 38068, Italy

Location

National Kyushu Medical Center

Fukuoka, 810-8563, Japan

Location

Saitama Medical University International Medical Center

Hidaka, 350-1298, Japan

Location

Hirosaki University Hospital

Hirosaki, 036-8563, Japan

Location

Hospital of the University of Occupational and Environmental Health

Kitakyushu, 807-8556, Japan

Location

Saiseikai Kumamoto Hospital

Kumamoto, 861-4193, Japan

Location

Kyorin University Hospital

Mitaka, 181-8611, Japan

Location

Iwate Medical University Hospital

Morioka, 020-8505, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Ogaki Municipal Hospital

Ōgaki, 503-8502, Japan

Location

Showa University Hospital

Shinagawa-Ku, 142-8555, Japan

Location

National Cerebral and Cardiovascular Center

Suita, 565-8565, Japan

Location

The Jikei University School of Medicine Hospital

Tokyo, 105-8471, Japan

Location

Toho University Omori Medical Center

Tokyo, 143-8541, Japan

Location

Fujita Health University Hospital

Toyoake, 470-1192, Japan

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Maastricht Universitair Medisch Centrum (MUMC)

Maastricht, Netherlands

Location

Centro Hospitalar Lisboa Ocidental - Hospital de Santa Cruz

Carnaxide, Portugal

Location

Hospital Senhora da Oliveira, Guimaraes

Guimarães, Portugal

Location

Centro Hospitarlar Lisboa Norte - Hospital de Santa Maria

Lisbon, Portugal

Location

Hospital do Espirito Santo

Ponta Delgada, Portugal

Location

Centro Hospitalar do Porto - Hospital de Santo Antonio

Porto, Portugal

Location

Hospital Distrital de Santarem

Santarém, Portugal

Location

King Fahd Armed Forces Hospital

Jeddah, 21159, Saudi Arabia

Location

Prince Sultan Cardiac Center

Riyadh, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 30487072 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Erika Pouliot
• Organization: Medtronic

erika.pouliot@medtronic.com

17635261270

Study Officials

• Suneet Mittal, M.D.

  The Valley Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: April 21, 2016
• Study Start: April 1, 2014
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: July 18, 2022
• Results First Posted: July 18, 2022

Record last verified: 2022-03

Locations

JP (14); US (19); IT (2); NL (2); GR (1); BE (1); PT (6); SA (2); IL (1)