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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 catheterization or electrophysiology (EP) laboratory).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| office setting | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 Months post insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Green Hospital | La Jolla | California | 92037 | United States | ||
| Saint Joseph Heritage Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32207636 | Derived | 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. | |
| 27825975 |
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4 subjects excluded prior to randomization for not meeting inclusion/exclusion criteria
525 subjects were assessed for eligibility
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| ID | Title | Description |
|---|---|---|
| FG000 | In Office Outside Walls of Hospital | Reveal LINQ insertions will be performed in office setting. Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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The site of the Reveal LINQ insertion was randomized. Therefore it was not possible to blind the subject or the investigator.
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| hosptial setting | Other | A hospital setting was defined as an operating room or electrophysiology lab inside the walls of a hospital. |
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| Mission Viejo |
| California |
| United States |
| Regional Cardiology Associates (Sacramento CA) | Sacramento | California | United States |
| Colorado Heart and Vascular, PC | Lakewood | Colorado | United States |
| Cardiac Arrhythmia Service | Boca Raton | Florida | United States |
| Clearwater Cardiovascular Consultants - Clearwater Office | Clearwater | Florida | United States |
| Jim Moran Heart & Vascular-Holy Cross Hospital | Fort Lauderdale | Florida | United States |
| Tallahassee Research Institute Inc | Tallahassee | Florida | United States |
| Georgia Arrhythmia Consultants | Macon | Georgia | United States |
| Saint Elizabeth Healthcare | Edgewood | Kentucky | United States |
| Delmarva Heart Research Foundation Inc | Salisbury | Maryland | United States |
| Sparrow Clinical Research Institute | Lansing | Michigan | 48912 | United States |
| Cardiology Associates of North Mississippi | Tupelo | Mississippi | United States |
| Mid America Heart Institute (MAHI) | Kansas City | Missouri | United States |
| Lester E Cox Medical Center | Springfield | Missouri | United States |
| Morristown Memorial Hospital | Newark | New Jersey | United States |
| Lourdes Cardiology Services | Voorhees Township | New Jersey | United States |
| Northwell Health | Great Neck | New York | United States |
| The Mount Sinai Medical Center (New York NY) | New York | New York | United States |
| Cone Health Medical Group HeartCare at Church Street | Greensboro | North Carolina | United States |
| Raleigh Cardiology Associates | Raleigh | North Carolina | United States |
| Oklahoma Heart Institute | Tulsa | Oklahoma | United States |
| Diagnostic Cardiology Group | Chattanooga | Tennessee | United States |
| Amarillo Heart Group | Amarillo | Texas | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | United States |
| Baylor Research Institute (Dallas TX) | Dallas | Texas | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | United States |
| 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. |
| Traditional Hospital Setting |
Reveal LINQ insertions will be performed in IN-a traditional setting Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in. |
| REVEAL LINQ Insertion | Number of subjects randomized that actually had a REVEAL LINQ insertion attempt |
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| COMPLETED |
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| NOT COMPLETED |
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The baseline analysis population is the number of randomized subjects that had a REVEAL LINQ insertion attempt
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| ID | Title | Description |
|---|---|---|
| BG000 | In Office Outside Walls of Hospital | Reveal LINQ insertions will be performed in office setting. Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in. |
| BG001 | Traditional Hospital Setting | Reveal LINQ insertions will be performed in IN-a traditional setting Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body mass index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
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| Cardiomyopathy | Count of Participants | Participants |
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| Congestive heart failure | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
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| Myocardial infarction | Count of Participants | Participants |
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| Prior stroke or transient ischemic attack | Count of Participants | Participants |
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| Unexplained syncope | Count of Participants | Participants |
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| Paroxysmal atrial fibrillation | Count of Participants | Participants |
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| Persistent/permanent atrial fibrillation | Count of Participants | Participants |
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| Diabetes | Count of Participants | Participants |
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| Renal dysfunction | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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) | Posted | Count of Participants | Participants | 3 Months post insertion |
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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.
An independent clinical events committee comprised on independent physicians who are not sponsor employees or study investigators and blinded to the subject's treatment arm adjudicated the relationship of each event to the REVEAL LINQ insertion procedure or system.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | In Office Outside Walls of Hospital | Reveal LINQ insertions will be performed in office setting. Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in. | 2 | 251 | 3 | 251 | 8 | 251 |
| EG001 | Traditional Hospital Setting | Reveal LINQ insertions will be performed in IN-a traditional setting Insertion of Reveal LINQ device in office or traditional hospital setting: The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in. | 0 | 231 | 0 | 231 | 11 | 231 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block complete | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Incision Site Haemorrhage | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
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| Cerebral Haemorrhage | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block complete | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Device dislocation | General disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Device extrusion | General disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Implant site bruising | General disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Implant site rash | General disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Incision site complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
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| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
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| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lindsay Werder, Senior Clinical Research Specialist | Medtronic, PLC | 7635268168 | lindsay.k.werder@medtronic.com |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Non-Inferiority |
A non-inferiority margin of 5% was chosen since the inability to rule out a 5% increase in untoward event rate associated with moving the Reveal LINQ procedure in-office may suggest that in-office procedures would too high of a complication rate compared procedures performed in the traditional office setting. |