Reveal LINQ Registry

Medtronic Cardiac Rhythm and Heart Failure1,604 enrolled

Overview

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

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

1,604

Conditions

Arrhythmias, Cardiac

Interventions

Reveal LINQDEVICE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (48)

Outcomes

Primary Outcomes

Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature

Clinical actions taken over the course of study follow-up

Time frame: 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.

Time frame: Implant to 30 days post-implant

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 38 more locations