CClinicalTrials.gg
CompletedNCT02412488RIO2Updated Feb 11, 2019Results posted

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

An interventional study of Out of cathlab insertion in Arrhythmia, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-02-11.

Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
191
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
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Study 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".

Read the 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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Conditions studied

  • Arrhythmia

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03

In context

Arrhythmias, Cardiac

885 studies on the registry are indexed under Arrhythmias, Cardiac; 234 are open to participants now.

This study's enrollment of 191 is above the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
191 participants (actual)

Study arms

  • Experimental
    Out of CathLab setting

    Out of cathlab insertion

    Other: Out of cathlab insertion

Interventions

  • OtherOut 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).

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What researchers measure

Primary outcomes

  1. Number of Participants With Untoward Events

    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)

    Time frame: 3 months

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Results

Posted Feb 11, 2019
Limitations and caveats
This was a single arm study

Participant flow

Participant flow — Overall Study
MilestoneOut of CathLab Setting
Started192
Reveal linq implanted191
Completed174
Not completed18
Withdrew: Lost to follow-up10
Withdrew: Withdrawal by subject5
Withdrew: Physician decision1
Withdrew: No reveal linq insertion attempt1
Withdrew: Reveal linq explant1

Outcome measures

PrimaryNumber of Participants With Untoward Events

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)

Time frame:
3 months
Reported as:
Count of participants · Participants
Number of Participants With Untoward Events
ParticipantsOut of CathLab Setting
Number of Participants With Untoward Events0
Statistical analysis
  • Out of CathLab Setting · Event rate expressed as a percent: 0 · 95% CI 0 to 2.1The estimate is the observed rate of untoward events expressed as a percentage. The 95% confidence interval is also expressed as a percentage

Adverse events

Collected over All adverse events that were Reveal LINQ related, Reveal LINQ procedure related including any infections potentially resulting from the LINQ device or procedure as well as all serious events regardless of their relationship to the LINQ device or procedure were collected.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Out of CathLab Setting0/191 (0%)3/191 (1.6%)7/191 (3.7%)
Most frequent serious events
Most frequent serious events
EventOut of CathLab Setting
Supraventricular tachycardiaCardiac disorders1/191
cerebrovascular accidentNervous system disorders1/191
syncopeNervous system disorders1/191
Most frequent other events
Most frequent other events
EventOut of CathLab Setting
Incision site haemorrhageInjury, poisoning and procedural complications2/191
Supraventricular tachycardiaCardiac disorders1/191
Implant site painGeneral disorders1/191
cerebrovascular accidentNervous system disorders1/191
PresyncopeNervous system disorders1/191
SyncopeNervous system disorders1/191

Baseline characteristics

Participants with Reveal LINQ Insertion Attempt

Age, Continuous
Age, Continuous(years)Out of CathLab Setting
Mean63.8 ± 26.9
Sex: Female, Male
Sex: Female, Male(Participants)Out of CathLab Setting
Female87
Male104
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Out of CathLab Setting
Region of Enrollment
Region of Enrollment(Participants)Out of CathLab Setting
Australia34
Canada28
Germany28
Italy15
Netherlands32
Spain35
Sweden1
United Kingdom15
Body Mass Index (kg/m^2)
Body Mass Index (kg/m^2)(kg/m^2)Out of CathLab Setting
Mean27.9 ± 4.8
Cardiomyopathy
Cardiomyopathy(Participants)Out of CathLab Setting
Count of participants10
Congestive Heart Failure
Congestive Heart Failure(Participants)Out of CathLab Setting
Count of participants2
Hypertension
Hypertension(Participants)Out of CathLab Setting
Count of participants87

4 further baseline measures are reported on the registry.

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Sanders P, Piorkowski C, Kragten JA, Goode GK, Raj SR, Dinh T, Sohail MR, Anand R, Moya-Mitjans A, Franco N, Stromberg K, Rogers JD. Safety of in-hospital insertable cardiac monitor procedures performed outside the traditional settings: results from the Reveal LINQ in-office 2 international study. BMC Cardiovasc Disord. 2019 May 31;19(1):132. doi: 10.1186/s12872-019-1106-3. PubMed 31151383 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02412488
Lead sponsor
Medtronic Cardiac Rhythm and Heart Failure
Responsible party
Sponsor
First posted
Apr 9, 2015
Start date
Feb 2015
Primary completion
Sep 22, 2016
Completion
Oct 20, 2016
Results posted
Feb 11, 2019
Last update
Feb 11, 2019

Study contacts

RIO2 Clinical Study Specialist
study chair · Medtronic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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