Trial Outcomes & Findings for Reveal LINQ™ In-Office 2 (RIO2) Study International (NCT NCT02412488)

Last Updated: 2019-02-11

Results Overview

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)

Recruitment status

COMPLETED

Study phase

Target enrollment

191 participants

Primary outcome timeframe

3 months

Results posted on

2019-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	Out of CathLab Setting The insertion of the Reveal LINQ device will be performed in the "out-of-cathlab" setting. Insertion of the Reveal LINQ device in the out of cathlab setting: Insertion of the Reveal LINQ device in the "out-of-cathlab" setting (out of the operating room, cardiac catheterization or electrophysiology laboratory).
Overall Study STARTED	192
Overall Study Reveal LINQ Implanted	191
Overall Study COMPLETED	174
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Out of CathLab Setting The insertion of the Reveal LINQ device will be performed in the "out-of-cathlab" setting. Insertion of the Reveal LINQ device in the out of cathlab setting: Insertion of the Reveal LINQ device in the "out-of-cathlab" setting (out of the operating room, cardiac catheterization or electrophysiology laboratory).
Overall Study Lost to Follow-up	10
Overall Study Withdrawal by Subject	5
Overall Study Physician Decision	1
Overall Study No Reveal LINQ Insertion Attempt	1
Overall Study Reveal LINQ explant	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Out of CathLab Setting n=191 Participants The insertion of the Reveal LINQ device will be performed in the "out-of-cathlab" setting. Insertion of the Reveal LINQ device in the out of cathlab setting: Insertion of the Reveal LINQ device in the "out-of-cathlab" setting (out of the operating room, cardiac catheterization or electrophysiology laboratory).
Age, Continuous	63.8 years STANDARD_DEVIATION 26.9 • n=191 Participants
Sex: Female, Male Female	87 Participants n=191 Participants
Sex: Female, Male Male	104 Participants n=191 Participants
Region of Enrollment Australia	34 Participants n=191 Participants
Region of Enrollment Canada	28 Participants n=191 Participants
Region of Enrollment Germany	28 Participants n=191 Participants
Region of Enrollment Italy	15 Participants n=191 Participants
Region of Enrollment Netherlands	32 Participants n=191 Participants
Region of Enrollment Spain	35 Participants n=191 Participants
Region of Enrollment Sweden	1 Participants n=191 Participants
Region of Enrollment United Kingdom	15 Participants n=191 Participants
Body Mass Index (kg/m^2)	27.9 kg/m^2 STANDARD_DEVIATION 4.8 • n=191 Participants
Cardiomyopathy	10 Participants n=191 Participants
Congestive Heart Failure	2 Participants n=191 Participants
Hypertension	87 Participants n=191 Participants
Myocardial infarction	3 Participants n=191 Participants
Unexplained syncope	83 Participants n=191 Participants
Diabetes	26 Participants n=191 Participants
Renal dysfunction	8 Participants n=191 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 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

Outcome measures

Outcome measures
Measure	Out of CathLab Setting n=176 Participants The insertion of the Reveal LINQ device will be performed in the "out-of-cathlab" setting. Insertion of the Reveal LINQ device in the out of cathlab setting: Insertion of the Reveal LINQ device in the "out-of-cathlab" setting (out of the operating room, cardiac catheterization or electrophysiology laboratory).
Number of Participants With Untoward Events	0 Participants

Adverse Events

Out of CathLab Setting

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Out of CathLab Setting n=191 participants at risk The insertion of the Reveal LINQ device will be performed in the "out-of-cathlab" setting. Insertion of the Reveal LINQ device in the out of cathlab setting: Insertion of the Reveal LINQ device in the "out-of-cathlab" setting (out of the operating room, cardiac catheterization or electrophysiology laboratory).
Cardiac disorders Supraventricular tachycardia	0.52% 1/191 • Number of events 1 • 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. An independent clinical events committee comprised of independent physicians who were not sponsor employees or study investigators adjudicated each reported event for its relationship to the Reveal LINQ system or procedure. All adverse event summaries are based on the clinical events committee's classification.
Nervous system disorders cerebrovascular accident	0.52% 1/191 • Number of events 1 • 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. An independent clinical events committee comprised of independent physicians who were not sponsor employees or study investigators adjudicated each reported event for its relationship to the Reveal LINQ system or procedure. All adverse event summaries are based on the clinical events committee's classification.
Nervous system disorders syncope	0.52% 1/191 • Number of events 1 • 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. An independent clinical events committee comprised of independent physicians who were not sponsor employees or study investigators adjudicated each reported event for its relationship to the Reveal LINQ system or procedure. All adverse event summaries are based on the clinical events committee's classification.

Other adverse events

Other adverse events
Measure	Out of CathLab Setting n=191 participants at risk The insertion of the Reveal LINQ device will be performed in the "out-of-cathlab" setting. Insertion of the Reveal LINQ device in the out of cathlab setting: Insertion of the Reveal LINQ device in the "out-of-cathlab" setting (out of the operating room, cardiac catheterization or electrophysiology laboratory).
Cardiac disorders Supraventricular tachycardia	0.52% 1/191 • Number of events 1 • 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. An independent clinical events committee comprised of independent physicians who were not sponsor employees or study investigators adjudicated each reported event for its relationship to the Reveal LINQ system or procedure. All adverse event summaries are based on the clinical events committee's classification.
General disorders Implant site pain	0.52% 1/191 • Number of events 1 • 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. An independent clinical events committee comprised of independent physicians who were not sponsor employees or study investigators adjudicated each reported event for its relationship to the Reveal LINQ system or procedure. All adverse event summaries are based on the clinical events committee's classification.
Injury, poisoning and procedural complications Incision site haemorrhage	1.0% 2/191 • Number of events 2 • 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. An independent clinical events committee comprised of independent physicians who were not sponsor employees or study investigators adjudicated each reported event for its relationship to the Reveal LINQ system or procedure. All adverse event summaries are based on the clinical events committee's classification.
Nervous system disorders cerebrovascular accident	0.52% 1/191 • Number of events 1 • 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. An independent clinical events committee comprised of independent physicians who were not sponsor employees or study investigators adjudicated each reported event for its relationship to the Reveal LINQ system or procedure. All adverse event summaries are based on the clinical events committee's classification.
Nervous system disorders Presyncope	0.52% 1/191 • Number of events 1 • 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. An independent clinical events committee comprised of independent physicians who were not sponsor employees or study investigators adjudicated each reported event for its relationship to the Reveal LINQ system or procedure. All adverse event summaries are based on the clinical events committee's classification.
Nervous system disorders Syncope	0.52% 1/191 • Number of events 1 • 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. An independent clinical events committee comprised of independent physicians who were not sponsor employees or study investigators adjudicated each reported event for its relationship to the Reveal LINQ system or procedure. All adverse event summaries are based on the clinical events committee's classification.

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