N/A
Completed N=1,604
Reveal LINQ Registry
Arrhythmias, Cardiac
Source: ClinicalTrials.gov NCT02746471 ↗
Enrolled (actual)
1,604
Serious AEs
4.0%
Results posted
Jul 2022
Primary outcomePrimary: Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature — 201; 75; 32; 9 Number of times action taken
Summary
The Reveal LINQ Registry will generate reliable long-term "real world" data of product performance, economic valuation, site-of-service procedural information.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature |
201; 75; 32; 9; 4; 176 | — |
| PRIMARY Number of Participants With Procedure-related Acute Infection Rate |
8 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02746471). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.