Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02700945
Recruitment Status : Active, not recruiting
First Posted : March 7, 2016
Results First Posted : November 9, 2021
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Stroke, Acute
Intervention Device: Reveal LINQ™ Insertable Cardiac Monitor
Enrollment 496
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Reveal LINQ™ Insertable Cardiac Monitor Control Arm
Hide Arm/Group Description

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.

Subjects randomized to the control arm will be followed per site specific standard of care.
Period Title: Overall Study
Started 242 250
Completed 210 207
Not Completed 32 43
Arm/Group Title Reveal LINQ™ Insertable Cardiac Monitor Control Arm Total
Hide Arm/Group Description

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.

Subjects randomized to the control arm will be followed per site specific standard of care. Total of all reporting groups
Overall Number of Baseline Participants 240 250 490
Hide Baseline Analysis Population Description
Two participants in the 'continuous monitoring' arm of the study did not collect baseline information after randomization.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 240 participants 250 participants 490 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
117
  48.8%
113
  45.2%
230
  46.9%
>=65 years
123
  51.2%
137
  54.8%
260
  53.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 240 participants 250 participants 490 participants
66.6  (9.3) 67.5  (9.5) 67.1  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 240 participants 250 participants 490 participants
Female
96
  40.0%
89
  35.6%
185
  37.8%
Male
144
  60.0%
161
  64.4%
305
  62.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 240 participants 250 participants 490 participants
240 250 490
Tobacco Use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 240 participants 250 participants 490 participants
130
  54.2%
133
  53.2%
263
  53.7%
Congestive Heart Failure  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 240 participants 250 participants 490 participants
28
  11.7%
23
   9.2%
51
  10.4%
Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 240 participants 250 participants 490 participants
197
  82.1%
200
  80.0%
397
  81.0%
Stroke/TIA/Thromboembolism  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 240 participants 250 participants 490 participants
240
 100.0%
250
 100.0%
490
 100.0%
Vascular Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 240 participants 250 participants 490 participants
45
  18.8%
47
  18.8%
92
  18.8%
1.Primary Outcome
Title The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin.
Hide Description 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Reveal LINQ™ Insertable Cardiac Monitor Control Arm
Hide Arm/Group Description:

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.

Subjects randomized to the control arm will be followed per site specific standard of care.
Overall Number of Participants Analyzed 240 250
Measure Type: Number
Unit of Measure: percentage of participants
12.1 1.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reveal LINQ™ Insertable Cardiac Monitor, Control Arm
Comments H0: h(t) = hT(t) for t ≤ 12 months HA: hC(t) ≠ hT(t) for t ≤ 12 months where hT(t) and hC(t) are the hazard functions of first detected and adjudicated AF at time t for subjects with and without the Reveal LINQ diagnostics for AF, respectively. Hazard functions and survival functions are transformations of each other.
Type of Statistical Test Superiority
Comments The 12-month Kaplan-Meier estimate will be reported for each arm. The hazard ratio estimate for the treatment effect with its 95% confidence interval will be reported.
Statistical Test of Hypothesis P-Value <0.001
Comments A priori threshold is .05
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 7.4
Confidence Interval (2-Sided) 95%
2.6 to 21.3
Estimation Comments A hazard ratio of > 1 indicates that continuous monitoring arm is superior to control arm in detecting AF.
2.Secondary Outcome
Title The Rate of AF Through the Duration of Study Follow-up Between Study Arms.
Hide Description 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.
Time Frame 3 years
Outcome Measure Data Not Reported
Time Frame We monitored adverse events up to the primary end point from enrollment, which was equivalent to 1 year.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Reveal LINQ™ Insertable Cardiac Monitor Control Arm
Hide Arm/Group Description

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.

Subjects randomized to the control arm will be followed per site specific standard of care.
All-Cause Mortality
Reveal LINQ™ Insertable Cardiac Monitor Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   5/242 (2.07%)      12/250 (4.80%)    
Hide Serious Adverse Events
Reveal LINQ™ Insertable Cardiac Monitor Control Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   58/242 (23.97%)      65/250 (26.00%)    
Blood and lymphatic system disorders     
Blood loss anaemia  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Haemorrhagic disorder  1  0/242 (0.00%)  0 2/250 (0.80%)  2
Cardiac disorders     
Acute coronary syndrome  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Acute myocardial infarction  1  7/242 (2.89%)  9 6/250 (2.40%)  7
Angina pectoris  1  0/242 (0.00%)  0 2/250 (0.80%)  2
Angina unstable  1  2/242 (0.83%)  2 0/250 (0.00%)  0
Aortic valve stenosis  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Arteriosclerosis coronary artery  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Atrial fibrillation  1  2/242 (0.83%)  2 7/250 (2.80%)  7
Atrioventricular block complete  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Atrioventricular block second degree  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Cardiac arrest  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Cardiac failure congestive  1  2/242 (0.83%)  2 1/250 (0.40%)  1
Cardiac failure  1  0/242 (0.00%)  0 1/250 (0.40%)  2
Coronary artery disease  1  3/242 (1.24%)  3 6/250 (2.40%)  6
Ischaemic cardiomyopathy  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Left ventricular failure  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Lupus endocarditis  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Myocardial infarction  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Myocardial ischaemia  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Nodal rhythm  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Pulseless electrical activity  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Sinus node dysfunction  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Supraventricular tachycardia  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Tachyarrhythmia  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Ventricular tachycardia  1  1/242 (0.41%)  1 1/250 (0.40%)  1
Vertebral artery stenosis  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Congenital, familial and genetic disorders     
Atrial septal defect  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Eye disorders     
Retinal artery occlusion  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal haemorrhage  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Intestinal ischaemia  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Intestinal perforation  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Upper gastrointestinal haemorrhage  1  1/242 (0.41%)  1 0/250 (0.00%)  0
General disorders     
Chest discomfort  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Chest pain  1  2/242 (0.83%)  2 1/250 (0.40%)  1
Death  1  0/242 (0.00%)  0 2/250 (0.80%)  2
Non-cardiac chest pain  1  1/242 (0.41%)  2 0/250 (0.00%)  0
Oedema peripheral  1  1/242 (0.41%)  1 1/250 (0.40%)  1
Infections and infestations     
COVID-19  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Pneumonia  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Sepsis  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Urosepsis  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Injury, poisoning and procedural complications     
Arteriovenous fistula thrombosis  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Incision site haemorrhage  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Post procedural haemorrhage  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Post procedural hypotension  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Subdural haematoma  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Wound haemorrhage  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Investigations     
Cardiac stress test abnormal  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Electrocardiogram T wave abnormal  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastatic carcinoma of the bladder  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Nervous system disorders     
Basal ganglia stroke  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Brain stem infarction  1  0/242 (0.00%)  0 3/250 (1.20%)  4
Carotid arteriosclerosis  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Carotid artery disease  1  1/242 (0.41%)  1 1/250 (0.40%)  1
Carotid artery stenosis  1  10/242 (4.13%)  10 12/250 (4.80%)  12
Cerebral infarction  1  1/242 (0.41%)  1 3/250 (1.20%)  3
Cerebrovascular accident  1  4/242 (1.65%)  4 5/250 (2.00%)  5
Dizziness  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Haemorrhage intracranial  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Hypertensive encephalopathy  1  1/242 (0.41%)  1 1/250 (0.40%)  1
Intraventricular haemorrhage  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Ischaemic cerebral infarction  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Ischaemic stroke  1  11/242 (4.55%)  13 14/250 (5.60%)  14
Lacunar infarction  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Stroke in evolution  1  1/242 (0.41%)  1 1/250 (0.40%)  1
Syncope  1  2/242 (0.83%)  2 2/250 (0.80%)  2
Transient ischaemic attack  1  2/242 (0.83%)  2 3/250 (1.20%)  4
Vascular dementia  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Dyspnoea  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Pulmonary embolism  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Vascular disorders     
Accelerated hypertension  1  0/242 (0.00%)  0 2/250 (0.80%)  2
Aortic aneurysm rupture  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Deep vein thrombosis  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Essential hypertension  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Hypertension  1  3/242 (1.24%)  3 1/250 (0.40%)  1
Hypertensive crisis  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Hypertensive emergency  1  2/242 (0.83%)  3 0/250 (0.00%)  0
Hypertensive urgency  1  2/242 (0.83%)  2 1/250 (0.40%)  1
Hypotension  1  3/242 (1.24%)  3 2/250 (0.80%)  2
Orthostatic hypotension  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Peripheral arterial occlusive disease  1  1/242 (0.41%)  1 1/250 (0.40%)  1
Peripheral vascular disorder  1  3/242 (1.24%)  3 1/250 (0.40%)  1
Subclavian steal syndrome  1  0/242 (0.00%)  0 1/250 (0.40%)  1
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Reveal LINQ™ Insertable Cardiac Monitor Control Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   69/242 (28.51%)      45/250 (18.00%)    
Cardiac disorders     
Angina pectoris  1  2/242 (0.83%)  2 1/250 (0.40%)  1
Atrial fibrillation  1  30/242 (12.40%)  30 3/250 (1.20%)  3
Atrial flutter  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Atrial tachycardia  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Bradycardia  1  4/242 (1.65%)  4 0/250 (0.00%)  0
Cardiac failure acute  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Cardiac failure chronic  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Cardiac failure congestive  1  2/242 (0.83%)  2 0/250 (0.00%)  0
Coronary artery disease  1  2/242 (0.83%)  2 0/250 (0.00%)  0
Palpitations  1  0/242 (0.00%)  0 2/250 (0.80%)  2
Sinus arrest  1  3/242 (1.24%)  3 0/250 (0.00%)  0
Sinus tachycardia  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Supraventricular extrasystoles  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Supraventricular tachycardia  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Tachycardia  1  0/242 (0.00%)  0 2/250 (0.80%)  2
Ventricular tachycardia  1  2/242 (0.83%)  2 0/250 (0.00%)  0
Eye disorders     
Diabetic retinopathy  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Retinal vein occlusion  1  0/242 (0.00%)  0 1/250 (0.40%)  1
General disorders     
Chest discomfort  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Chest pain  1  1/242 (0.41%)  1 2/250 (0.80%)  2
Implant site pain  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Oedema peripheral  1  1/242 (0.41%)  1 1/250 (0.40%)  1
Infections and infestations     
Implant site infection  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Injury, poisoning and procedural complications     
Incision site haemorrhage  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Investigations     
Blood pressure increased  1  0/242 (0.00%)  0 1/250 (0.40%)  1
C-reactive protein abnormal  1  0/242 (0.00%)  0 2/250 (0.80%)  2
Troponin increased  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Nervous system disorders     
Ischaemic stroke  1  2/242 (0.83%)  2 0/250 (0.00%)  0
Presyncope  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Stroke in evolution  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Syncope  1  2/242 (0.83%)  2 4/250 (1.60%)  4
Transient ischaemic attack  1  3/242 (1.24%)  3 2/250 (0.80%)  2
Reproductive system and breast disorders     
Breast tenderness  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea exertional  1  1/242 (0.41%)  1 0/250 (0.00%)  0
Dyspnoea  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Vascular disorders     
Aortic aneurysm  1  0/242 (0.00%)  0 1/250 (0.40%)  1
Deep vein thrombosis  1  1/242 (0.41%)  1 1/250 (0.40%)  1
Essential hypertension  1  1/242 (0.41%)  1 3/250 (1.20%)  3
Hypertension  1  13/242 (5.37%)  13 18/250 (7.20%)  19
Hypotension  1  1/242 (0.41%)  1 6/250 (2.40%)  6
Peripheral vascular disorder  1  1/242 (0.41%)  1 1/250 (0.40%)  1
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
The attribution of stroke mechanism is subjective and may have led to the enrollment of a population at higher risk of underlying embolism. However, this attribution reflects real-world practice and our sample is representative of patients in whom ICM decisions need to be made. The assignment to ICM versus control was not blinded, however our study endpoint was adjudicated using objective criteria. Our study was not powered to detect a significant difference in rates of recurrent stroke.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Carola Alfaro Vives
Organization: Medtronic
Phone: 763-526-1539
EMail: carola.alfaro.vives@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT02700945    
Other Study ID Numbers: Stroke AF
First Submitted: March 2, 2016
First Posted: March 7, 2016
Results First Submitted: August 5, 2021
Results First Posted: November 9, 2021
Last Update Posted: November 9, 2021