Reveal LINQ™ In-Office 2 (RIO2) Study International (RIO2)

September 12, 2018 updated by: Medtronic Cardiac Rhythm and Heart Failure

Reveal LINQ™ In-Office 2 (RIO2) International Study

The purpose of the RIO 2 International study is to provide clinical and economic evidence to support moving the LINQ™ insertion procedure outside these traditional locations within the hospital, referred to as "out-of-cathlab".

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The traditional location of the LINQ™ insertion procedure is the catheterization laboratory, electrophysiology laboratory, or operating room. The purpose of the RIO 2 International study is to provide clinical and economic evidence to support moving the LINQ™ insertion procedure outside these traditional locations within the hospital, referred to as "out-of-cathlab".

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
191

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is indicated for continuous arrhythmia monitoring with a Reveal LINQ™ Insertable Cardiac Monitor (ICM)
  • Patient is at least 18 years of age or older if required by local regulations
  • Patient is willing to undergo ICM insertion procedure outside of the cathlab, operating room, or EP lab setting with only local anesthetic
  • Patient is willing and able to provide consent and authorize the use and disclosure of health information
  • Patient is willing and able to comply with the elements of the clinical investigation plan including the required follow-up

Exclusion Criteria:

  • Patient has unusual thoracic anatomy or scarring at the insertion site which may adversely affect the success of the insertion procedure
  • Patient has reduced immune function or is otherwise at high risk for infection per physician discretion
  • Current therapy with immunosuppressive agents or chronic steroid use e.g. Prednisone greater than 20mg per day
  • Patient requires hemodialysis
  • Patient with active malignancy or history of chemotherapy or radiation treatment
  • Patient has had a recent (within 30 days) or an active infection including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia
  • Patient has had major surgery (in the past 6 months) Patient has undergone a procedure which required central venous or intra-arterial access (e.g. AF/VT ablation, EP study, coronary angiography) within the last 3 months or is scheduled for such a procedure while enrolled in the study
  • Prior history of surgical infection, prosthetic device infection, or endovascular infection, including endocarditis, in the past 12 months
  • Patient has a central venous port, an atrio-venous fistula, or a prosthetic valve
  • Patient requires conscious or moderate sedation to receive LINQ™
  • Patient already has an inserted or implanted loop recorder
  • Patient is implanted or indicated for implant with a pacemaker, ICD, CRT device
  • Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager
  • Patient's life expectancy is less than 6 months
  • Patient is legally incapable of giving consent
  • Patient is pregnant* *Note: Possible pregnancy will be assessed by the physician asking the patient; a pregnancy test is not required

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Out of CathLab setting
Out of cathlab insertion
Other: Out of cathlab insertion
Insertion of the Reveal LINQ device in the "out-of-cathlab" setting (out of the operating room, cardiac catheterization or electrophysiology laboratory).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Untoward Events
Time Frame: 3 months

An untoward event is a composite endpoint defined as a LINQTM or LINQTM insertion procedure related complication OR an unsuccessful LINQTM insertion procedure, where a LINQTM or LINQTM insertion procedure related complication is defined as an adverse event related to the LINQTM or a LINQTM insertion procedure resulting in:

  • Death
  • Termination of significant device function
  • Invasive intervention (e.g. includes LINQTM revision/explant for reasons other than diagnosis of underlying condition, intravenous drug administration)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiac Rhythm and Heart Failure

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: RIO2 Clinical Study Specialist, Medtronic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 22, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RIO2 International

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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