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The Reveal LINQ Registry will generate reliable long-term "real world" data of product performance, economic valuation, site-of-service procedural information.
Condition or disease
Device: Reveal LINQ
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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
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.