Trial Outcomes & Findings for Reveal LINQ Registry (NCT NCT02746471)

NCT ID: NCT02746471

Last Updated: 2022-07-18

Results Overview

Clinical actions taken over the course of study follow-up

• Recruitment status: COMPLETED
• Target enrollment: 1604 participants
• Primary outcome timeframe: Implant to 36 months post-implant
• Results posted on: 2022-07-18

Participant Flow

Participant milestones

Measure	Registry 1604 subjects were enrolled in the study from 55 centers in US, EMEA and Saudi Arabia. Follow-up data collection ended on 04 Jun 2021.
Overall Study STARTED	1604
Overall Study COMPLETED	442
Overall Study NOT COMPLETED	1162

Reasons for withdrawal

Measure	Registry 1604 subjects were enrolled in the study from 55 centers in US, EMEA and Saudi Arabia. Follow-up data collection ended on 04 Jun 2021.
Overall Study Death	43
Overall Study Exited before 36 months	1119

Baseline Characteristics

Reveal LINQ Registry

Baseline characteristics by cohort

Measure	LINQ Subjects n=1604 Participants Subjects who were confirmed to have been implanted with a LINQ device
Age, Categorical <=18 years	28 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	770 Participants n=5 Participants
Age, Categorical >=65 years	806 Participants n=5 Participants
Age, Continuous	61.7 years STANDARD_DEVIATION 16.8 • n=5 Participants
Sex: Female, Male Female	682 Participants n=5 Participants
Sex: Female, Male Male	922 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	233 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	47 Participants n=5 Participants
Race (NIH/OMB) White	877 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	435 Participants n=5 Participants
Region of Enrollment Greece	32 participants n=5 Participants
Region of Enrollment Saudi Arabia	42 participants n=5 Participants
Region of Enrollment Netherlands	41 participants n=5 Participants
Region of Enrollment Belgium	35 participants n=5 Participants
Region of Enrollment United States	920 participants n=5 Participants
Region of Enrollment Japan	215 participants n=5 Participants
Region of Enrollment Italy	166 participants n=5 Participants
Region of Enrollment Israel	8 participants n=5 Participants
Region of Enrollment Portugal	101 participants n=5 Participants
Region of Enrollment Germany	27 participants n=5 Participants
Region of Enrollment United Kingdom	6 participants n=5 Participants
Region of Enrollment Spain	11 participants n=5 Participants
NYHA Class I	27 Participants n=5 Participants
NYHA Class II	27 Participants n=5 Participants
NYHA Class III	9 Participants n=5 Participants
NYHA Not Available	195 Participants n=5 Participants
NYHA Patient does not have Heart Failure	1346 Participants n=5 Participants
Reason for Implant AF Management	177 Participants n=5 Participants
Reason for Implant Cryptogenic Stroke	291 Participants n=5 Participants
Reason for Implant Palpitations	177 Participants n=5 Participants
Reason for Implant Post-AF Ablation Monitoring	78 Participants n=5 Participants
Reason for Implant Pre-AF Ablation Monitoring	27 Participants n=5 Participants
Reason for Implant Seizures	2 Participants n=5 Participants
Reason for Implant Suspected AF	178 Participants n=5 Participants
Reason for Implant Syncope	540 Participants n=5 Participants
Reason for Implant Transient Ischemic Attack (TIA)	9 Participants n=5 Participants
Reason for Implant Ventricular Tachycardia	49 Participants n=5 Participants
Reason for Implant Other	76 Participants n=5 Participants

PRIMARY outcome

Timeframe: Implant to 36 months post-implant

Population: Subjects who had an opportunity to have an action taken after ICM insertion

Clinical actions taken over the course of study follow-up

Outcome measures

Measure	Registry n=1604 Participants 1604 subjects were enrolled in the study from 55 centers in US, EMEA and Saudi Arabia. Follow-up data collection ended on 04 Jun 2021.
Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature AF Ablation	201 Number of times action taken
Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature Electrical Cardioversion	75 Number of times action taken
Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature PFO Closure	4 Number of times action taken
Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature Therapeutic Device Implanted	176 Number of times action taken
Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature Aortic valve replacement	1 Number of times action taken
Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature Placement of a Watchman device	1 Number of times action taken
Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature Stopped OAC medication at least once during study (was on at baseline)	141 Number of times action taken
Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature Started OAC medication at least once during study (was off at baseline)	176 Number of times action taken
Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature Other Ablation	32 Number of times action taken
Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature PCI	9 Number of times action taken

PRIMARY outcome

Timeframe: Implant to 30 days post-implant

Population: Same as arm/group description

Acute infection rate in the subjects who were followed for at least 30 days or had an infection prior to 30 days. Infections are as assessed by the Investigator and defined as deep incision site or superficial infection.

Deep incision site are classified as pain, redness, or drainage at incision site requiring the device to be removed or IV antibiotics administered.

Superficial infections are defined as redness beyond procedure expectation and oral antibiotics administered.

For both deep incision and superficial infections, a physician directed intervention must occur for the event to be defined as an infection.

Outcome measures

Measure	Registry n=1261 Participants 1604 subjects were enrolled in the study from 55 centers in US, EMEA and Saudi Arabia. Follow-up data collection ended on 04 Jun 2021.
Number of Participants With Procedure-related Acute Infection Rate	8 Participants

Adverse Events

Registry

Serious events: 64 serious events

Other events: 0 other events

Deaths: 43 deaths

Serious adverse events

Measure	Registry n=1604 participants at risk 1604 subjects were enrolled in the study from 55 centers in US, EMEA and Saudi Arabia. Follow-up data collection ended on 04 Jun 2021.
Nervous system disorders Cerebrovascular accident	0.94% 15/1604 • Number of events 16 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Cardiac disorders Atrial fibrillation	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Cardiac disorders Atrioventricular block complete	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Nervous system disorders Brain stem haemorrhage	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Cardiac disorders Cardio-respiratory arrest	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Nervous system disorders Cerebellar haemorrhage	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Nervous system disorders Cerebral artery embolism	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Nervous system disorders Cerebral haemorrhage	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Nervous system disorders Cerebral infarction	0.12% 2/1604 • Number of events 2 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
General disorders Chest pain	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Product Issues Device dislocation	0.12% 2/1604 • Number of events 2 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Product Issues Device expulsion	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Product Issues Device extrusion	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Nervous system disorders Embolic stroke	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Vascular disorders Haemorrhage	0.19% 3/1604 • Number of events 3 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Nervous system disorders Haemorrhagic stroke	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Metabolism and nutrition disorders Hyponatraemia	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Infections and infestations Infection	0.25% 4/1604 • Number of events 4 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Nervous system disorders Ischaemic stroke	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Cardiac disorders Myocardial infarction	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Cardiac disorders Pericarditis	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Infections and infestations Pneumonia	0.06% 1/1604 • Number of events 2 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Injury, poisoning and procedural complications Pocket erosion	0.25% 4/1604 • Number of events 5 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Injury, poisoning and procedural complications Postoperative respiratory distress	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Cardiac disorders Sinus node dysfunction	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Injury, poisoning and procedural complications Subdural haematoma	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Cardiac disorders Supraventricular tachycardia	0.06% 1/1604 • Number of events 2 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Nervous system disorders Transient ischaemic attack	0.50% 8/1604 • Number of events 8 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Reproductive system and breast disorders Uterine polyp	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Cardiac disorders Ventricular extrasystoles	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Cardiac disorders Ventricular fibrillation	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Infections and infestations Wound infection	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
Cardiac disorders Bradycardia	0.06% 1/1604 • Number of events 1 • Up to 36 months of study enrollment Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Erika Pouliot

Medtronic

Phone: 17635261270

Email: erika.pouliot@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee In most cases, contracts allow investigators ("PI") to publish per the publication strategy/Clinical Investigation Plan following Medtronic's review for (a) disclosure of confidential information ("CI"), and (b) selection and order of publications by the publications committee. Any such CI is deleted prior to publication/presentation. Medtronic may not otherwise censor/interfere with the publication. PI's may not publish single-site data until the main multi-site publication has occurred.
• Publication restrictions are in place

Restriction type: OTHER