ArrhythmiaRIO 2NCT02395536

Medtronic Reveal LINQ™ In-Office 2 (RIO 2) Study United States

A study testing office setting and hosptial setting in people with Arrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 27 sites in United States.

Completed

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

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Arrhythmia
What is being tested?: office setting and hosptial setting
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 525 participants
Where: 27 sitesUnited States
Study dates: 30 Mar 2015to 31 May 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
Patient is 18 years of age or older
Patient is willing to undergo ICM insertion procedure outside of the cath lab, 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 protocol including the required follow-up

Who cannot join

Patient has unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant 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)

Show all 15Show fewer

Patient has undergone a procedure which required central venous or intraarterial access (e.g. AF/VT ablation, EP study, coronary angio) 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 is already implanted with a 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 pregnant

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Amarillo Heart Group
Amarillo, Texas
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas
Cardiac Arrhythmia Service
Boca Raton, Florida
Diagnostic Cardiology Group
Chattanooga, Tennessee
Clearwater Cardiovascular Consultants - Clearwater Office
Clearwater, Florida
Baylor Research Institute (Dallas TX)
Dallas, Texas
Saint Elizabeth Healthcare
Edgewood, Kentucky
Jim Moran Heart & Vascular-Holy Cross Hospital
Fort Lauderdale, Florida
Northwell Health
Great Neck, New York
Cone Health Medical Group HeartCare at Church Street
Greensboro, North Carolina
Mid America Heart Institute (MAHI)
Kansas City, Missouri
Scripps Green Hospital
La Jolla, California, 92037
Colorado Heart and Vascular, PC
Lakewood, Colorado
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
Georgia Arrhythmia Consultants
Macon, Georgia
Saint Joseph Heritage Healthcare
Mission Viejo, California
The Mount Sinai Medical Center (New York NY)
New York, New York
Morristown Memorial Hospital
Newark, New Jersey
Sentara Norfolk General Hospital
Norfolk, Virginia
Raleigh Cardiology Associates
Raleigh, North Carolina
Regional Cardiology Associates (Sacramento CA)
Sacramento, California
Delmarva Heart Research Foundation Inc
Salisbury, Maryland
Lester E Cox Medical Center
Springfield, Missouri
Tallahassee Research Institute Inc
Tallahassee, Florida
Oklahoma Heart Institute
Tulsa, Oklahoma
Cardiology Associates of North Mississippi
Tupelo, Mississippi
Lourdes Cardiology Services
Voorhees Township, New Jersey

Other trials in United States

About this study

Official title: Reveal LINQ™ In-Office 2 (RIO 2) Study United States

Read the detailed description

RIO 2 is a two arm, randomized, prospective, un-blinded, multicenter, non-significant risk study. The primary objective for RIO 2 will be assessed by randomizing subjects to receive their LINQ™ insertion in the office setting or in the traditional hospital environment. Moving the LINQ™ insertion procedure to the office setting is not expected to decrease the complication rate compared to in hospital insertion procedures, however, moving the LINQ™ insertion procedure out of the traditional hospital setting may benefit the patient and reduce the burden to the healthcare system.

Conditions: Arrhythmia
Being tested: office setting, hosptial setting
Medical subject headings: Arrhythmias, Cardiac

What participants receive

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

office settingOther
An office setting was defined as a procedure or office room with controlled entry and hard floors outside the walls of the hospital and not including ambulatory surgical centers
hosptial settingOther
A hospital setting was defined as an operating room or electrophysiology lab inside the walls of a hospital.

Study groups in NCT02395536
Study group	Role	What they receive
In office Outside walls of hospital	Experimental	Reveal LINQ insertions will be performed in office setting. The in office setting was defined as a procedure or office room with controlled entry and hard floors outside the walls of the hospital and not an ambulatory surgery center. Receives: Other: office setting
Traditional Hospital Setting	Other	Reveal LINQ insertions will be performed in a traditional setting. The traditional hospital setting includes an operating room or electrophysiology laboratory. Receives: Other: hosptial setting

What is being measured

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

Untoward Event Rate Associated With LINQ™ Insertions Performed
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.
Measured: 3 Months post insertion

Timeline

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

30 Mar 201531 May 2016

First posted23 Mar 2015 (estimated)
Study start30 Mar 2015
Primary completion31 May 2016
Study completion31 May 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 (2)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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 525 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02395536
Sponsor's protocol ID: Version 1.0, 23 January 2015
Acronym: RIO 2
Status last verified: May 2017
First submitted: 17 Mar 2015
Last updated: 4 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Rogers JD, Piorkowski C, Sohail MR, Anand R, Kowalski M, Rosemas S, Stromberg K, Sanders P. Resource utilization associated with hospital and office-based insertion of a miniaturized insertable cardiac monitor: results from the RIO 2 randomized US study. J Med Econ. 2020 Jul;23(7):706-713. doi: 10.1080/13696998.2020.1746548. Epub 2020 May 1.
PubMed 32207636
Rogers JD, Sanders P, Piorkowski C, Sohail MR, Anand R, Crossen K, Khairallah FS, Kaplon RE, Stromberg K, Kowal RC. In-office insertion of a miniaturized insertable cardiac monitor: Results from the Reveal LINQ In-Office 2 randomized study. Heart Rhythm. 2017 Feb;14(2):218-224. doi: 10.1016/j.hrthm.2016.11.001. Epub 2016 Nov 4.
PubMed 27825975

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?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reveal LINQ™ In-Office 2 (RIO 2) Study United States
ClinicalTrials.gov ID: NCT02395536
Acronym / sponsor ID: RIO 2 / Version 1.0, 23 January 2015
Conditions: Arrhythmia
Study type: Interventional
Recruitment status: Completed
Enrolment: 525 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: 30 Mar 2015 (actual)
Primary completion: 31 May 2016 (actual)
Study completion: 31 May 2016 (actual)
First posted: 23 Mar 2015 (estimated)
Results: Posted 4 Oct 2017

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
In office Outside walls of hospital	Experimental	Other: office settingReveal LINQ insertions will be performed in office setting. The in office setting was defined as a procedure or office room with controlled entry and hard floors outside the walls of the hospital and not an ambulatory surgery center.
Traditional Hospital Setting	Other	Other: hosptial settingReveal LINQ insertions will be performed in a traditional setting. The traditional hospital setting includes an operating room or electrophysiology laboratory.

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
Patient is 18 years of age or older
Patient is willing to undergo ICM insertion procedure outside of the cath lab, 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 protocol including the required follow-up

Key exclusion criteria (15 listed)

Patient has unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant 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.

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
office settingAn office setting was defined as a procedure or office room with controlled entry and hard floors outside the walls of the hospital and not including ambulatory surgical centers	Other	In office Outside walls of hospital
hosptial settingA hospital setting was defined as an operating room or electrophysiology lab inside the walls of a hospital.	Other	Traditional Hospital Setting

Primary outcome

Untoward Event Rate Associated With LINQ™ Insertions Performed
Time frame: 3 Months post insertion
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.

Results and safety

Results posted to the registry on 4 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
In Office Outside Walls of Hospital	264	244
Traditional Hospital Setting	257	227

Primary outcome: Untoward Event Rate Associated With LINQ™ Insertions Performed

Time frame: 3 Months post insertion. Count of participants. Unit: Participants

Measure	In Office Outside Walls of Hospital n = 244	Traditional Hospital Setting n = 227
Value	2	2

In Office Outside Walls of Hospital vs Traditional Hospital Setting: Risk Difference (RD): -0.001 (95% CI -0.030 to 0.029), p <0.001, Farrington-Manning test

Population analysed: Subjects exiting prematurely (prior to 3-month visit) without an untoward event were excluded from primary analysis. There were 7 excluded from the In office arm (2 deaths unrelated to the REVEAL LINQ and 5 premature exits) and 4 excluded from the traditional hospital setting arm (all 4 due to premature exit)

Adverse events

Time frame: All adeverse events potentially related to the REVEAL LINQ insertion procedure or system were collected from consent through the end of study participation (3-months post-procedure). Additionally all deaths were collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
In Office Outside Walls of Hospital	3 of 251 (1.2%)	8 of 251 (3.2%)	2 of 251
Traditional Hospital Setting	0 of 231 (0%)	11 of 231 (4.8%)	0 of 231

Limitations and caveats (from the sponsor): It was not possible to blind either the subject or implanting physician. The study exit rate after randomization but prior to REVEAL LINQ procedure was relatively high, but not unexpected given randomization needed to occur prior to the procedure.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32207636Rogers JD, Piorkowski C, Sohail MR, Anand R, Kowalski M, Rosemas S, Stromberg K, Sanders P. Resource utilization associated with hospital and office-based insertion of a miniaturized insertable cardiac monitor: results from the RIO 2 randomized US study. J Med Econ. 2020 Jul;23(7):706-713. doi: 10.1080/13696998.2020.1746548. Epub 2020 May 1.
Derived from this study: PubMed 27825975Rogers JD, Sanders P, Piorkowski C, Sohail MR, Anand R, Crossen K, Khairallah FS, Kaplon RE, Stromberg K, Kowal RC. In-office insertion of a miniaturized insertable cardiac monitor: Results from the Reveal LINQ In-Office 2 randomized study. Heart Rhythm. 2017 Feb;14(2):218-224. doi: 10.1016/j.hrthm.2016.11.001. Epub 2016 Nov 4.
Individual participant dataSharing planned: No

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RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
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Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
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Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
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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.

The record lists no contact. Use the official record to reach the sponsor.

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing office setting and hosptial setting in people with Arrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 27 sites in United States.

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 15 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 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 4 Oct 2017). 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?

Untoward Event Rate Associated With LINQ™ Insertions Performed (time frame: 3 Months post insertion). 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 NCT02395536, which also lists 2 linked publications.

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 4 Oct 2017.