Trial Outcomes & Findings for Medtronic Reveal LINQ™ In-Office 2 (RIO 2) Study United States (NCT NCT02395536)

Last Updated: 2017-10-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

525 participants

Primary outcome timeframe

3 Months post insertion

Results posted on

2017-10-04

Participant Flow

525 subjects were assessed for eligibility

4 subjects excluded prior to randomization for not meeting inclusion/exclusion criteria

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	264	257
Overall Study REVEAL LINQ Insertion	251	231
Overall Study COMPLETED	244	227
Overall Study NOT COMPLETED	20	30

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	4	4
Overall Study Death	2	0
Overall Study Physician Decision	4	6
Overall Study Withdrawal by Subject	9	17
Overall Study Inclusion/Excusion Criteria Violation	1	2
Overall Study Insurance issue	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	In Office Outside Walls of Hospital n=251 Participants 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.	Traditional Hospital Setting n=231 Participants 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.	Total n=482 Participants Total of all reporting groups
Age, Continuous	64.3 years STANDARD_DEVIATION 14.0 • n=251 Participants	63.9 years STANDARD_DEVIATION 14.9 • n=231 Participants	64.1 years STANDARD_DEVIATION 14.4 • n=482 Participants
Sex: Female, Male Female	117 Participants n=251 Participants	125 Participants n=231 Participants	242 Participants n=482 Participants
Sex: Female, Male Male	134 Participants n=251 Participants	106 Participants n=231 Participants	240 Participants n=482 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	251 participants n=251 Participants	231 participants n=231 Participants	482 participants n=482 Participants
Body mass index (kg/m^2)	30.3 kg/m^2 STANDARD_DEVIATION 7.5 • n=251 Participants	29.6 kg/m^2 STANDARD_DEVIATION 7.1 • n=231 Participants	30.0 kg/m^2 STANDARD_DEVIATION 7.3 • n=482 Participants
Cardiomyopathy	9 Participants n=251 Participants	8 Participants n=231 Participants	17 Participants n=482 Participants
Congestive heart failure	5 Participants n=251 Participants	9 Participants n=231 Participants	14 Participants n=482 Participants
Hypertension	162 Participants n=251 Participants	146 Participants n=231 Participants	308 Participants n=482 Participants
Myocardial infarction	13 Participants n=251 Participants	10 Participants n=231 Participants	23 Participants n=482 Participants
Prior stroke or transient ischemic attack	69 Participants n=251 Participants	58 Participants n=231 Participants	127 Participants n=482 Participants
Unexplained syncope	48 Participants n=251 Participants	76 Participants n=231 Participants	124 Participants n=482 Participants
Paroxysmal atrial fibrillation	81 Participants n=251 Participants	68 Participants n=231 Participants	149 Participants n=482 Participants
Persistent/permanent atrial fibrillation	14 Participants n=251 Participants	14 Participants n=231 Participants	28 Participants n=482 Participants
Diabetes	43 Participants n=251 Participants	53 Participants n=231 Participants	96 Participants n=482 Participants
Renal dysfunction	7 Participants n=251 Participants	14 Participants n=231 Participants	21 Participants n=482 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	In Office Outside Walls of Hospital n=244 Participants 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.	Traditional Hospital Setting n=227 Participants 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.
Untoward Event Rate Associated With LINQ™ Insertions Performed	2 Participants	2 Participants

Adverse Events

In Office Outside Walls of Hospital

Serious events: 3 serious events

Other events: 8 other events

Deaths: 2 deaths

Traditional Hospital Setting

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	In Office Outside Walls of Hospital n=251 participants at risk 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.	Traditional Hospital Setting n=231 participants at risk 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.
Cardiac disorders Atrioventricular block complete	0.40% 1/251 • Number of events 1 • 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.	0.00% 0/231 • 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.
Injury, poisoning and procedural complications Incision Site Haemorrhage	0.40% 1/251 • Number of events 1 • 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.	0.00% 0/231 • 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.
Nervous system disorders Cerebral Haemorrhage	0.40% 1/251 • Number of events 1 • 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.	0.00% 0/231 • 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.

Other adverse events

Other adverse events
Measure	In Office Outside Walls of Hospital n=251 participants at risk 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.	Traditional Hospital Setting n=231 participants at risk 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.
Cardiac disorders Atrioventricular block complete	0.40% 1/251 • Number of events 1 • 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.	0.00% 0/231 • 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.
Cardiac disorders Supraventricular tachycardia	0.00% 0/251 • 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.	0.43% 1/231 • Number of events 1 • 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.
General disorders Device dislocation	0.40% 1/251 • Number of events 1 • 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.	0.43% 1/231 • Number of events 1 • 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.
General disorders Device extrusion	0.00% 0/251 • 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.	0.43% 1/231 • Number of events 1 • 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.
General disorders Implant site bruising	0.00% 0/251 • 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.	0.43% 1/231 • Number of events 1 • 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.
General disorders Implant site rash	0.00% 0/251 • 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.	0.43% 1/231 • Number of events 1 • 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.
Injury, poisoning and procedural complications Incision site complication	0.40% 1/251 • Number of events 1 • 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.	0.00% 0/231 • 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.
Injury, poisoning and procedural complications Incision site haemorrhage	0.80% 2/251 • Number of events 2 • 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.	1.3% 3/231 • Number of events 3 • 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.
Injury, poisoning and procedural complications Procedural dizziness	0.80% 2/251 • Number of events 2 • 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.	0.00% 0/231 • 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.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/251 • 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.	0.43% 1/231 • Number of events 1 • 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.
Nervous system disorders Cerebral haemorrhage	0.40% 1/251 • Number of events 1 • 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.	0.00% 0/231 • 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.
Nervous system disorders Presyncope	0.00% 0/251 • 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.	0.43% 1/231 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Rash	0.00% 0/251 • 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.	0.43% 1/231 • Number of events 1 • 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.

Additional Information

Lindsay Werder, Senior Clinical Research Specialist

Medtronic, PLC

Phone: 7635268168

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place