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NCT02395536 · ClinicalTrials.gov registry record · NA
Medtronic Reveal LINQ™ In-Office 2 (RIO 2) Study United States
A NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- NA
- Development phase
- 525
- Enrollment target
NCT02395536: Completed NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT02395536 is a NA study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 525 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02395536, a NA study, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- NA
- Development phase
- 525 participants
- Enrollment target
Study Summary
The primary purpose of the RIO 2 study is to demonstrate that when the Reveal LINQ™ insertable cardiac monitoring (ICM) system that records subcutaneous ECG insertion procedure performed in the in-office setting is as safe as LINQ™ insertions performed in the traditional hospital setting (operating room, cardiac catheterization or electrophysiology (EP) laboratory).
Primary Outcome
Demonstrate that the untoward event rate associated with Reveal LINQ™ insertions performed in-office or in the traditional hospital setting (operating room, cardiac catheterization or EP laboratory) are comparable. Untoward events are a composite of unsuccessful Reveal LINQ™ or complications related to the Reveal LINQ™ insertion procedure or system.
Interventions
- OTHER office setting
- OTHER hosptial setting
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 525 participants |
| Start Date | 2015-03-30 |
| Est. Completion | 2016-05-31 |
| Phase | NA |
What the finished NCT02395536 record still lists
NCT02395536 is an interventional study that assigns participants to a tested intervention. The registered 525 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which office setting is the first listed.
NCT02395536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02395536 about?
NCT02395536 is a clinical study titled "Medtronic Reveal LINQ™ In-Office 2 (RIO 2) Study United States". The primary purpose of the RIO 2 study is to demonstrate that when the Reveal LINQ™ insertable cardiac monitoring (ICM) system that records subcutaneous ECG insertion procedure performed in the in-office setting is as safe as LINQ™ insertions performed in the traditional hospital setting (operating ...
What is the current status of trial NCT02395536?
This trial is currently completed. It is a NA study. The enrollment target is 525 participants. The study started on 2015-03-30. Estimated completion is 2016-05-31.
What interventions are being tested in trial NCT02395536?
The interventions under investigation include: office setting (OTHER), hosptial setting (OTHER).
Who is sponsoring clinical trial NCT02395536?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02395536's enrollment target sits among peer trials
525 189th of 2000 higher than 1,812 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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