ArrhythmiaRIO2NCT02412488

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

A study testing Out of cathlab insertion in people with Arrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Arrhythmia
What is being tested?: Out of cathlab insertion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 191 participants
Where: No sites listed yet
Study dates: Feb 2015to 20 Oct 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 16Show fewer

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

About this study

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

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".

Conditions: Arrhythmia
Being tested: Out of cathlab insertion
Medical subject headings: Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Out of cathlab insertionOther
Insertion of the Reveal LINQ device in the "out-of-cathlab" setting (out of the operating room, cardiac catheterization or electrophysiology laboratory).

Study groups in NCT02412488
Study group	Role	What they receive
Out of CathLab setting	Experimental	Out of cathlab insertion Receives: Other: Out of cathlab insertion

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201520 Oct 2016

First posted9 Apr 2015 (estimated)
Study startFeb 2015
Primary completion22 Sep 2016
Study completion20 Oct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ArrhythmiaStudies of the same condition, open and under way.
More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 191 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02412488
Sponsor's protocol ID: RIO2 International
Acronym: RIO2
Status last verified: Sep 2018
First submitted: 6 Apr 2015
Last updated: 11 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
RecruitingObservational study
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Arrhythmia, Bradycardia
Recruiting
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
Arrhythmias, Cardiac
RecruitingObservational study
An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias
Arrhythmias, Cardiac

All Arrhythmia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reveal LINQ™ In-Office 2 (RIO2) International Study
ClinicalTrials.gov ID: NCT02412488
Acronym / sponsor ID: RIO2 / RIO2 International
Conditions: Arrhythmia
Study type: Interventional
Recruitment status: Completed
Enrolment: 191 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: Feb 2015
Primary completion: 22 Sep 2016 (actual)
Study completion: 20 Oct 2016 (actual)
First posted: 9 Apr 2015 (estimated)
Results: Posted 11 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Out of CathLab setting	Experimental	Other: Out of cathlab insertionOut of cathlab insertion

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Out of cathlab insertionInsertion of the Reveal LINQ device in the "out-of-cathlab" setting (out of the operating room, cardiac catheterization or electrophysiology laboratory).	Other	Out of CathLab setting

Primary outcome

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)

Results and safety

Results posted to the registry on 11 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Out of CathLab Setting	192	174

Primary outcome: Number of Participants With Untoward Events

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Out of CathLab Setting n = 176
Value	0

Out of CathLab Setting: Event Rate expressed as a percent: 0 (95% CI 0 to 2.1)

Population analysed: Subjects exiting prematurely (prior to 3-month visit) without an untoward event were excluded from the primary analysis. There were 15 subjects exited prior to the 3-month visit all due to premature exit without having an untoward event

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Out of CathLab Setting	3 of 191 (1.6%)	7 of 191 (3.7%)	0 of 191

Limitations and caveats (from the sponsor): This was a single arm study

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31151383Sanders 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.
Individual participant dataSharing planned: No

Related trials for Arrhythmia

Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
RecruitingObservational study
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Arrhythmia, Bradycardia
Recruiting
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
Arrhythmias, Cardiac
RecruitingObservational study
An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias
Arrhythmias, Cardiac

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

RIO2 Clinical Study Specialist study chair

Medtronic

Questions about this trial

What is this clinical trial studying?

A study testing Out of cathlab insertion in people with Arrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Untoward Events (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02412488, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.