Arrhythmia
Conditions
Brief 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 catheterization or electrophysiology (EP) laboratory).
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.
Interventions
OTHERoffice setting
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
OTHERhosptial setting
A hospital setting was defined as an operating room or electrophysiology lab inside the walls of a hospital.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
The site of the Reveal LINQ insertion was randomized. Therefore it was not possible to blind the subject or the investigator.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is indicated for continuous arrhythmia monitoring with a Reveal LINQ™ Insertable Cardiac Monitor 2. Patient is 18 years of age or older 3. Patient is willing to undergo ICM insertion procedure outside of the cath lab, OR, EP lab setting with only local anesthetic 4. Patient is willing and able to provide consent and authorize the use and disclosure of health information 5. Patient is willing and able to comply with the protocol including the required follow-up
Exclusion criteria
1. Patient has unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure 2. Patient has reduced immune function or is otherwise at high risk for infection per physician discretion 3. Current therapy with immunosuppressive agents or chronic steroid use e.g. Prednisone greater than 20mg per day 4. Patient requires hemodialysis 5. 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. 6. Patient has had major surgery (in the past 6 months) 7. 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. 8. Prior history of surgical infection, prosthetic device infection, or endovascular infection, including endocarditis, in the past 12 months. 9. Patient has a central venous port, an atrio-venous fistula, or a prosthetic valve 10. Patient requires conscious or moderate sedation to receive LINQ™ 11. Patient is already implanted with a loop recorder 12. Patient is implanted or indicated for implant with a pacemaker, ICD, CRT device 13. Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager. 14. Patient's life expectancy is less than 6 months 15. Patient is pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Untoward Event Rate Associated With LINQ™ Insertions Performed | 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. |
Countries
United States
Participant flow
Recruitment details
525 subjects were assessed for eligibility
Pre-assignment details
4 subjects excluded prior to randomization for not meeting inclusion/exclusion criteria
Participants by arm
| Arm | Count |
|---|---|
| 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. | 251 |
| 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. | 231 |
| Total | 482 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 0 |
| Overall Study | Inclusion/Excusion Criteria Violation | 1 | 2 |
| Overall Study | Insurance issue | 0 | 1 |
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | Physician Decision | 4 | 6 |
| Overall Study | Withdrawal by Subject | 9 | 17 |
Baseline characteristics
| Characteristic | In Office Outside Walls of Hospital | Traditional Hospital Setting | Total |
|---|---|---|---|
| Age, Continuous | 64.3 years STANDARD_DEVIATION 14 | 63.9 years STANDARD_DEVIATION 14.9 | 64.1 years STANDARD_DEVIATION 14.4 |
| Body mass index (kg/m^2) | 30.3 kg/m^2 STANDARD_DEVIATION 7.5 | 29.6 kg/m^2 STANDARD_DEVIATION 7.1 | 30.0 kg/m^2 STANDARD_DEVIATION 7.3 |
| Cardiomyopathy | 9 Participants | 8 Participants | 17 Participants |
| Congestive heart failure | 5 Participants | 9 Participants | 14 Participants |
| Diabetes | 43 Participants | 53 Participants | 96 Participants |
| Hypertension | 162 Participants | 146 Participants | 308 Participants |
| Myocardial infarction | 13 Participants | 10 Participants | 23 Participants |
| Paroxysmal atrial fibrillation | 81 Participants | 68 Participants | 149 Participants |
| Persistent/permanent atrial fibrillation | 14 Participants | 14 Participants | 28 Participants |
| Prior stroke or transient ischemic attack | 69 Participants | 58 Participants | 127 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 251 participants | 231 participants | 482 participants |
| Renal dysfunction | 7 Participants | 14 Participants | 21 Participants |
| Sex: Female, Male Female | 117 Participants | 125 Participants | 242 Participants |
| Sex: Female, Male Male | 134 Participants | 106 Participants | 240 Participants |
| Unexplained syncope | 48 Participants | 76 Participants | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 251 | 0 / 231 |
| other Total, other adverse events | 8 / 251 | 11 / 231 |
| serious Total, serious adverse events | 3 / 251 | 0 / 231 |
Outcome results
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.
Time frame: 3 Months post insertion
Population: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| In Office Outside Walls of Hospital | Untoward Event Rate Associated With LINQ™ Insertions Performed | 2 Participants |
| Traditional Hospital Setting | Untoward Event Rate Associated With LINQ™ Insertions Performed | 2 Participants |
Comparison: The null hypothesis was that Reveal LINQ insertions performed in-office would have a higher untoward event rate than insertions performed in the traditional hospital setting. A sample size of 476 subjects was estimated to provide at least 90% power at a 1-sided alpha level of 2.5% and 5% non-inferiority margin. For the sample size calculation, an event rate of 2.0% was assumed in both arms. The Farrington-Manning test of two indepent proportions was used to compare study arms.p-value: <0.00195% CI: [-0.03, 0.029]Farrington-Manning test