Reveal LINQ Registry

Medtronic

Status: Completed

Conditions: Arrhythmias, Cardiac

Treatments: Device: Reveal LINQ

Study type: Observational

Funder types: Industry

Identifiers

NCT02746471

Reveal LINQ Registry

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,604 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design