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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02412488
Recruitment Status : Completed
First Posted : April 9, 2015
Results First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:
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".

Condition or disease Intervention/treatment Phase
Arrhythmia Other: Out of cathlab insertion Not Applicable

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".

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Reveal LINQ™ In-Office 2 (RIO2) International Study
Study Start Date : February 2015
Actual Primary Completion Date : September 22, 2016
Actual Study Completion Date : October 20, 2016

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02412488


Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Study Chair: RIO2 Clinical Study Specialist Medtronic

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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT02412488     History of Changes
Other Study ID Numbers: RIO2 International
First Posted: April 9, 2015    Key Record Dates
Results First Posted: February 11, 2019
Last Update Posted: February 11, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No