Trial Outcomes & Findings for Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin (NCT NCT02700945)

Last Updated: 2023-05-26

Results Overview

AF will be defined as an AF event lasting more than 30 seconds. The first AF episode detected and adjudicated by the endpoint adjudication committee will be used for this analysis.

Recruitment status

COMPLETED

Study phase

Target enrollment

496 participants

Primary outcome timeframe

12 months

Results posted on

2023-05-26

Participant Flow

We enrolled 496 participants in the study but only 492 were randomized. Three participants were enrolled but did not meet eligibility criteria, the fourth withdrew consent.

Participant milestones

Participant milestones
Measure	Reveal LINQ™ Insertable Cardiac Monitor Subjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device. Reveal LINQ™ Insertable Cardiac Monitor: The Medtronic Reveal LINQ™ ICM is a programmable device that continuously monitors a patient's ECG (electrocardiogram) and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient activation.	Control Arm Subjects randomized to the control arm will be followed per site specific standard of care.
Overall Study STARTED	242	250
Overall Study COMPLETED	210	207
Overall Study NOT COMPLETED	32	43

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reveal LINQ™ Insertable Cardiac Monitor n=240 Participants Subjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device. Reveal LINQ™ Insertable Cardiac Monitor: The Medtronic Reveal LINQ™ ICM is a programmable device that continuously monitors a patient's ECG (electrocardiogram) and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient activation.	Control Arm n=250 Participants Subjects randomized to the control arm will be followed per site specific standard of care.	Total n=490 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=240 Participants	0 Participants n=250 Participants	0 Participants n=490 Participants
Age, Categorical Between 18 and 65 years	117 Participants n=240 Participants	113 Participants n=250 Participants	230 Participants n=490 Participants
Age, Categorical >=65 years	123 Participants n=240 Participants	137 Participants n=250 Participants	260 Participants n=490 Participants
Age, Continuous	66.6 years STANDARD_DEVIATION 9.3 • n=240 Participants	67.5 years STANDARD_DEVIATION 9.5 • n=250 Participants	67.1 years STANDARD_DEVIATION 9.4 • n=490 Participants
Sex: Female, Male Female	96 Participants n=240 Participants	89 Participants n=250 Participants	185 Participants n=490 Participants
Sex: Female, Male Male	144 Participants n=240 Participants	161 Participants n=250 Participants	305 Participants n=490 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	240 participants n=240 Participants	250 participants n=250 Participants	490 participants n=490 Participants
Tobacco Use	130 Participants n=240 Participants	133 Participants n=250 Participants	263 Participants n=490 Participants
Congestive Heart Failure	28 Participants n=240 Participants	23 Participants n=250 Participants	51 Participants n=490 Participants
Hypertension	197 Participants n=240 Participants	200 Participants n=250 Participants	397 Participants n=490 Participants
Stroke/TIA/Thromboembolism	240 Participants n=240 Participants	250 Participants n=250 Participants	490 Participants n=490 Participants
Vascular Disease	45 Participants n=240 Participants	47 Participants n=250 Participants	92 Participants n=490 Participants

PRIMARY outcome

Timeframe: 12 months

AF will be defined as an AF event lasting more than 30 seconds. The first AF episode detected and adjudicated by the endpoint adjudication committee will be used for this analysis.

Outcome measures

Outcome measures
Measure	Reveal LINQ™ Insertable Cardiac Monitor n=242 Participants Subjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device. Reveal LINQ™ Insertable Cardiac Monitor: The Medtronic Reveal LINQ™ ICM is a programmable device that continuously monitors a patient's ECG (electrocardiogram) and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient activation.	Control Arm n=250 Participants Subjects randomized to the control arm will be followed per site specific standard of care.
The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin.	12.5 percentage of participants	1.8 percentage of participants

SECONDARY outcome

Timeframe: 3 years

AF will be defined as an AF event lasting more than 30 seconds. The first AF episode detected and adjudicated by the endpoint adjudication committee will be used for this analysis.

Outcome measures

Outcome measures
Measure	Reveal LINQ™ Insertable Cardiac Monitor n=242 Participants Subjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device. Reveal LINQ™ Insertable Cardiac Monitor: The Medtronic Reveal LINQ™ ICM is a programmable device that continuously monitors a patient's ECG (electrocardiogram) and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient activation.	Control Arm n=250 Participants Subjects randomized to the control arm will be followed per site specific standard of care.
The Rate of AF Through the Duration of Study Follow-up (36 Months) Between Study Arms.	21.7 percentage of participants	2.4 percentage of participants

Adverse Events

Reveal LINQ™ Insertable Cardiac Monitor

Serious events: 58 serious events

Other events: 69 other events

Deaths: 5 deaths

Control Arm

Serious events: 65 serious events

Other events: 45 other events

Deaths: 12 deaths

Serious adverse events

Other adverse events

Additional Information

Carola Alfaro Vives

Medtronic

Phone: 763-526-1539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Reveal LINQ™ Insertable Cardiac Monitor n=242 participants at risk Subjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device. Reveal LINQ™ Insertable Cardiac Monitor: The Medtronic Reveal LINQ™ ICM is a programmable device that continuously monitors a patient's ECG (electrocardiogram) and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient activation.	Control Arm n=250 participants at risk Subjects randomized to the control arm will be followed per site specific standard of care.
Cardiac disorders Angina pectoris	0.83% 2/242 • Number of events 2 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.40% 1/250 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Vascular disorders Aortic aneurysm	0.00% 0/242 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.40% 1/250 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Cardiac disorders Atrial fibrillation	12.4% 30/242 • Number of events 30 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	1.2% 3/250 • Number of events 3 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Cardiac disorders Atrial flutter	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Cardiac disorders Atrial tachycardia	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Investigations Blood pressure increased	0.00% 0/242 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.40% 1/250 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Cardiac disorders Bradycardia	1.7% 4/242 • Number of events 4 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Reproductive system and breast disorders Breast tenderness	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Investigations C-reactive protein abnormal	0.00% 0/242 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.80% 2/250 • Number of events 2 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Cardiac disorders Cardiac failure acute	0.00% 0/242 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.40% 1/250 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Cardiac disorders Cardiac failure chronic	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Cardiac disorders Cardiac failure congestive	0.83% 2/242 • Number of events 2 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
General disorders Chest discomfort	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
General disorders Chest pain	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.80% 2/250 • Number of events 2 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Cardiac disorders Coronary artery disease	0.83% 2/242 • Number of events 2 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Vascular disorders Deep vein thrombosis	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.40% 1/250 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Eye disorders Diabetic retinopathy	0.00% 0/242 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.40% 1/250 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/242 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.40% 1/250 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Vascular disorders Essential hypertension	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	1.2% 3/250 • Number of events 3 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Vascular disorders Hypertension	5.4% 13/242 • Number of events 13 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	7.2% 18/250 • Number of events 19 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Vascular disorders Hypotension	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	2.4% 6/250 • Number of events 6 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Infections and infestations Implant site infection	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
General disorders Implant site pain	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Injury, poisoning and procedural complications Incision site haemorrhage	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Nervous system disorders Ischaemic stroke	0.83% 2/242 • Number of events 2 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
General disorders Oedema peripheral	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.40% 1/250 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Cardiac disorders Palpitations	0.00% 0/242 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.80% 2/250 • Number of events 2 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Vascular disorders Peripheral vascular disorder	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.40% 1/250 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Nervous system disorders Presyncope	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Eye disorders Retinal vein occlusion	0.00% 0/242 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.40% 1/250 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Cardiac disorders Sinus arrest	1.2% 3/242 • Number of events 3 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Cardiac disorders Sinus tachycardia	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Nervous system disorders Stroke in evolution	0.00% 0/242 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.40% 1/250 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Cardiac disorders Supraventricular extrasystoles	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Cardiac disorders Supraventricular tachycardia	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Nervous system disorders Syncope	0.83% 2/242 • Number of events 2 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	1.6% 4/250 • Number of events 4 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Cardiac disorders Tachycardia	0.00% 0/242 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.80% 2/250 • Number of events 2 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Nervous system disorders Transient ischaemic attack	1.2% 3/242 • Number of events 3 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.80% 2/250 • Number of events 2 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Investigations Troponin increased	0.41% 1/242 • Number of events 1 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Cardiac disorders Ventricular tachycardia	0.83% 2/242 • Number of events 2 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.	0.00% 0/250 • We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.