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
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
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