Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke
Phase: NA
Conditions: Ischemic Stroke
Sponsor: Northwell Health

IRB 14-336 
ClinicalTrials.gov NCT02232022 
 
 
 
 
 
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TITLE 
 
Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke 
 
PRINCIPAL INVESTIGATOR: 
 
Jeffrey M. Katz, MD 
 
CO-INVESTIGATORS: 
 
Richard Libman, MD, Ram Jadonath, MD, Rohan Arora, MD, Anand Patel, MBBS, Ana Garlitzki, 
MD 
 
CAMPUS: 
 
North Shore University Hospital 
 
INTRODUCTION/BACKGROUND MATERIAL/PRELIMINARY STUDIES AND 
SIGNIFICANCE 
 
Atrial Fibrillation (AF) is an independent risk factor for stroke.1 Between 50 and 59 years of age, 
1.5% of strokes are attributed to AF, but between 80 and 89 years of age the proportion increases 
to 23.5%. There are 15 strokes every hour from AF.  
 
Paroxysmal AF (PAF) is sporadic, asymptomatic and has similar risk of stroke when compared to 
continuous AF.2,3 It is not clearly defined in the literature and is more prevalent than persistent AF 
in patients with ischemic stroke and TIA.4 The incidence of paroxysmal AF in cryptogenic stroke 
is 1 in 6 for age > 55 and 1 in 5 for age > 75.5 Most studies based on the prevalence of stroke in the 
US would suggest that approximately 200,000 individuals may have ischemic stroke associated 
with PAF. We suspect this number to be higher since long-term monitoring has been restricted 
only to the cryptogenic stroke population. The risk of stroke recurrence is four times greater 
among stroke patients with newly detected AF (15.5%) compared to those with either known AF 
or no AF (3.9%).6 Some studies have shown that 5% to 30% of cryptogenic strokes may be due to 
undetected AF.7,8 
 
The standard Holter monitor has a low sensitivity for detecting paroxysmal AF following an 
ischemic stroke (approximately 5%). In the recent Crystal AF study, 30% of cryptogenic stroke 
patients randomized to the Reveal Insertable Cardiac Monitor were found to have PAF compared 
to 3% of controls over a 3 year monitoring period.8,9 There are numerous observational studies that 
support greater detection of AF with longer monitoring. (Table 1)10,11 Median time to AF episode 
detection was 84 days. Prior studies have shown that long term monitoring for detection of PAF is 
cost effective. 12 While the relatively high incidence of silent PAF in cryptogenic stroke patients is 
just now being elucidated, there is no understanding of the frequency of silent PAF in patients with 
a “known” or presumed etiology for their ischemic stroke other than AF. If this incidence were 
also found to be significant, a dramatic change in stroke evaluation and management would likely 
occur. 
 

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Anticoagulation is the treatment of choice for AF and paroxysmal AF.13 Anticoagulation in 
patients with paroxysmal or chronic AF reduces the risk of stroke by 64% and death by 25%.5 The 
identification of paroxysmal AF in EMBRACE (30 day) and SURPRISE (mean 133 days) led to a 
change in management to full anticoagulation in 13% and 18% of patients, respectively. 
In the Crystal AF study, 97% of patients who were diagnosed with AF were changed to oral 
anticoagulants. 8 It is postulated that in the era of the novel oral anticoagulants, the detection of AF 
and the appropriate initiation of anticoagulation as secondary stroke prevention will reduce the risk 
of recurrent ischemic stroke without increasing the rates of symptomatic intracerebral hemorrhage 
or systemic hemorrhage. For patients with a presumed stroke mechanism other than AF who are 
found to have silent PAF, a change in management to full anticoagulation could have similar 
effects. 
 
OBJECTIVE(S)/SPECIFIC AIMS AND HYPOTHESES 
 
Primary Objective: 
To determine the incidence of paroxysmal atrial fibrillation (AF) in ischemic stroke patients 
who have a presumed known stroke etiology other than atrial fibrillation. 
       
Secondary Objectives:  
1. Percentage of patients who are diagnosed with AF who are changed to anticoagulant 
therapy. 
2. Duration and frequency of AF episodes. 
3. Percentage of asymptomatic AF episodes. 
4. Incidence of recurrent ischemic stroke. 
 
SUBJECT SELECTION – ELIGIBILITY CRITERIA 
 
The subject population will include patients with a diagnosis of Ischemic stroke. A total of 75 
patients will be enrolled over a 2-year period. 
 
 
 
Inclusion Criteria: 
 
Patients with a recent ischemic stroke or TIA with brain infarction on brain 
imaging. 
1. No history of atrial fibrillation or finding of atrial fibrillation on standard 
inpatient monitoring (ECG, telemetry, 24-hour Holter monitor) 
2.   Have a presumed stroke etiology: Lacunar or small vessel thrombosis, 
extra-cranial or intracranial atherosclerotic stenosis or dissection, 
arteriopathy or vasculitis, hypercoagulable state, aortic arch plaque with or 
without mobile elements, or evidence of a low-risk cardiac source (e.g., 
PFO with or without atrial septal aneurysm and with or without evidence 
of venous thromboembolic source).  
 
The following diagnostic tests are minimally required to determine the 
stroke etiology: 
• Brain MRI  
• 12-lead ECG for AF detection 

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• 24-h ECG monitoring for AF detection (eg, Holter monitor or cardiac 
telemetry) 
• TTE and/or TEE 
• CTA or MRA of head and neck 
• Hypercoagulable blood panel for patients less than 55 years-old 
• Preliminary hypercoagulable work-up within 7 days will include 
the antiphospholipid antibody syndrome results, which will be 
needed to determine stroke management. All other results, which 
could take longer to return, including genetic tests of 
hypercoagulability, rarely change stroke management. 
 
1. Have virtual CHADS2 score ≥3, or 
2. Have 2 or more of the following co-morbidities: obstructive sleep apnea, 
coronary artery disease, (Chronic Pulmonary Obstructive Disease 
(COPD), hyperthyroidism, BMI > 30, prior MI, prolonged PR interval 
(>175 ms) or renal impairment (GFR 30-60).  
 
3. Patient or legally authorized representative who is willing to sign written 
consent form. 
4. Patient is ≥40 years old (patients younger than 40 years old have a very 
low likelihood of having atrial fibrillation and are therefore excluded from 
the study). 
5. Patient can have the device implanted within 10 days of the incident 
ischemic event 
 
 
Exclusion Criteria: 
 
1. Documented history of AF or atrial flutter. 
2. Evidence of a high-risk cardiac source of embolism (LV or LA thrombus or 
“smoke,” emboligenic valvular lesion or tumor) 
3. Untreated hyperthyroidism. 
4. Myocardial infarction or coronary bypass grafting within 1 month prior to the 
stroke/TIA. 
5. Valvular disease requiring immediate surgical intervention. 
6. Permanent indication for anticoagulation at enrollment. 
7. Permanent oral anticoagulation contraindication. 
8. Already included in another clinical trial that will affect the objectives of this 
study. 
9. Life expectancy is less than 1 year. 
10. Pregnancy. Urine or serum pregnancy test is required for women of child bearing 
potential to exclude pregnancy. 
11. Patient is indicated for implant with a pacemaker, ICD, CRT device, or an 
implantable hemodynamic monitoring system 
12. Patient is not fit, or is unable or unwilling to follow the required procedures of the 
Clinical Investigation Plan. 
13. Cryptogenic Stroke: A stroke/TIA will be considered cryptogenic if no cause is 
determined despite extensive inpatient workup (see Inclusion criteria) according 
to the standard diagnostic protocol at North Shore University Hospital 

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DESIGN: 
 
This is a single center prospective, non-blinded, cohort study that will be conducted over a period 
of 3 years (2 year patient enrollment and a minimum of 12 months of ICM monitoring). Patients 
will be evaluated according to standard institutional stroke/TIA clinical guidelines. Participants 
will be recruited within 7 days after the diagnosis of a stroke once diagnostic tests have been 
completed and a presumed stroke etiology has been identified. 
 
All eligible patients will be approached for an informed consent to participate in the study. 
The primary goal of the study is to detect paroxysmal atrial fibrillation (AF) in ischemic stroke 
patients who have a presumed or known stroke etiology other than AF. The detection of 
paroxysmal AF will very likely lead to a change in their secondary stroke prevention strategy. 
 
Stroke or TIA is considered to be cryptogenic if no stroke mechanism can be determined after an 
evaluation according to the standards of American and European Guidelines. Such patients will be 
excluded from the study. 
 
Reveal LINQ Insertable Cardiac Monitor: 
 
The LINQ ICM (Medtronic, Inc.; See photo in Appendix B) is a small cardiac monitor implanted 
in the subcutaneous tissue of the chest wall that is designed to continuously record a single-lead 
ECG, monitoring the cardiac rhythm for up to three years. A previous study of a similar device 
(Reveal XT ICM; Medtronic, Inc.) has demonstrated the technology’s ability to correctly identify 
AF in 96.1% of patients and to correctly exclude AF in 97.4% of patients. The LINQ ICM (or 
future iterations) will be utilized in this study to detect occult paroxysmal AF in our study 
population. The LINQ ICM is approved by the FDA for use in patients where there is a suspicion 
of occult cardiac arrhythmias and is therefore being utilized in this study in accordance with the 
FDA labeling. 
 
The LINQ device is 87 % smaller than the Reveal device. It is pre-loaded in the insertion tool. The 
size of the device is 1.2 cc and it is interrogated using external equipment. It is able to store 4 
separate patient activated events in the electrogram. 
 
EP Cardiology, directed by Dr. Jadonath, will be implanting the device and have been trained by 
the manufacturer of the device. The cardiologists have been implanting similar devices for several 
years and have been trained on this specific device since February 2014. The insertion procedure 
involves draping the patient followed by local anesthesia at the site of implant. This is done under 
sterile precautions. A small incision is made under local anesthesia. Electrocautery to achieve 
hemostatis is rarely required. The device is then inserted using the insertion tool provided in the 
device kit. There is a risk of local site bleeding, infection, device migration, allergy to the device 
component, cosmetic complications from incision and inability of the device to capture some 
particular arrhythmias. 
  

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The best location of insertion of the device is 45 degrees relative to sternum over the 4th 
intercostals space (V2-V3) electrode orientation. This assures good signal quality. The second best 
option is 4th intercostals space approximately 2 cm parallel to the edge of sternum.  
If the above-recommended locations are not suitable, optional locations must be considered.  
The device is compatible with mammography and MRI (1.5T and 3T magnets).  For precautions 
related to these procedures please refer to Reveal LINQ ICM Medical Procedure Manual (to be 
attached to this document.) 
 
LINQ settings for high sensitivity and specificity will be set to: 
o AF only – All Episodes  
-The device will store all AF episodes that are irregular. Capture of these episodes is not 
based on the ventricular rate, it is based on irregularity. 
- Stored episodes are representative of the first two minutes of each episodes 
 
- Device will store approximately 13 episodes of 2 minutes duration (max 27 minutes)  
o Balanced Sensitivity   
o Ectopic Rejection: Aggressive 
 
Follow Up: 
 
Device recording of an AF episode of at least 2 minute duration will be required to diagnose a 
patient with AF.  A partial device transmission (summary of potential AF episodes) will be 
automatically downloaded daily via the Medtronic MyCareLink patient monitor and the study 
cardiologist will receive an alert within 24-48 hours if the computer monitoring system confirms 
an episode to be probable AF. Participants may also use the Reveal Patient Assistant to activate 
recording of cardiac information in the Reveal LINQ ICM while experiencing or immediately after 
a symptomatic event. Participants will be required to perform a manual device interrogation on a 
monthly basis. All downloaded rhythms will be manually reviewed every month for each enrolled 
patient by the study cardiologist. Each AF episode will also be independently adjudicated by a 
cardiologist blinded to the study protocol. 
 
A total of 75 patients will be enrolled in the study. After enrollment, patients will have study visits 
at 1, 6, and 12 months. Six and 12 month follow-up visits will be conducted at these time intervals 
plus or minus 30 days. If the patient cannot come in for a follow-up visit, then the follow-up may 
be performed as a telephone interview. During the study visits, patients will be assessed for any 
interval stroke or TIA-like events, intracerebral hemorrhages, interval medical history, device 
related complications or other adverse events. At the 1-month visit, a NIH stroke scale score will 
be obtained. At each study visit, a modified Rankin score will be recorded. There will not be any 
research labs conducted at these study visits and only blood work associated with routine care may 
be obtained. 
 
Patients will also have one EP cardiology clinical follow-up visit 10 days (plus or minus 4 days) 
after device implantation to ensure proper healing of the surgical site and functioning of the 
device. 
 
At the completion of the study, if there is no clinical reason not to remove the device, then the 
device will be removed at 1 year from implantation. If there is a clinical indication for longer 
monitoring, then the device will be kept in longer for a maximum of 3 years. However, if clinical 
monitoring is required beyond the study period, then monitoring will be performed outside of the 

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study, and the patient or the patient’s insurance will be responsible for any clinical fees associated 
with this post study monitoring.  
 
At the conclusion of the study, Drs. Jadonath or Garlitzki will be primarily responsible for 
removing the device; however, they may appoint one of their colleagues as designee to remove the 
device if they are unavailable. 
 
INFORMED CONSENT 
 
Subjects meeting the above inclusion/exclusion criteria will be approached by a study physician 
investigator and invited to participate in the study. If the patient agrees the study investigator will 
guide the patient through the informed consent process. All enrollees will undergo a detailed 
informed consent process during which risks, benefits and alternatives of participation will be 
discussed.   
 
In the case of diminished or altered capacity, the assessment of the subject’s decision making 
capacity will be made by the treating Stroke Neurologist. If the subject is deemed incapable of 
making his or her own health-care decision, a legally authorized representative (LAR) may be 
assigned. If the patient is awake, alert, and oriented and demonstrates appropriate cognitive and 
communicative abilities as determined by the interviewing/treating physician, the patient will be 
deemed to have the appropriate capacity to consent, as defined in the North Shore University 
Hospital Policies and Procedures Manual, Informed Consent, Policy No. 100.23, Pg 3.  
 
If the patient is deemed not to have the appropriate capacity to consent at the time of interview and 
a next of kin (NOK; spouse, adult child, parent, adult sibling, other relative) is available, that 
individual will be deemed the LAR (see North Shore University Hospital Policies and Procedures 
Manual, Informed Consent, Policy No. 100.23, Pg 4). Deeming a NOK as the LAR is necessary 
since stroke patients frequently lack capacity immediately following a stroke and because these 
patients are at high risk of recurrent stroke. This risk is especially high and relevant for patients 
who have undiagnosed atrial fibrillation, and who, therefore, would not be on appropriate 
antithrombotic therapy for secondary stroke prevention.  
 
If the patient’s decisional capacity is impaired, but the treating Stroke Neurologist deems the 
patient capable of assenting to study participation, then the patient and their LAR will be included 
in the informed consent process. In this case, enrollment will proceed only if the patient assents 
and the LAR gives consent to study enrollment. In the event that the participant is decisionally 
impaired to the point where both consent and assent cannot be obtained for the study, consent will 
be obtained from the LAR. In any other situation where the patient is deemed not to have the 
capacity to consent, the decision will be made not to enroll the patient in the study. All 
clarifications will be handled directly by the principal investigator.  
 
The use of an LAR will be documented on the data collection form. Enrollment into the study after 
the informed consent process is completed will be documented in the medical record. In the event 
that an LAR consents on behalf of a patient lacking capacity, continuing informed consent will be 
obtained if the treating physician or study physician determines that the patient regains the 
capacity to consent during the course of the protocol. Assessment for regaining capacity to 
participate in the informed consent process will be performed at each study visit. 
 

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STATISTICAL ANALYSIS 
Descriptive statistics (mean ± standard deviation and median for continuous data such as age; 
frequencies and percentages for categorical data such as gender, medical history, etc) will be 
calculated for baseline patient characteristics.   
 
The incidence of AF will be calculated as the total number of patients with AF in 12 months 
divided by the total number of patients studied, along with the corresponding 95% confidence 
interval.   
 
The analysis of “time-to-first-documented-AF” will be accomplished by applying standard 
methods of survival analysis, i.e., computing the Kaplan-Meier1 product limit curves.  In cases 
where the endpoint event, “AF”, had not yet occurred, 12 months will be used and considered 
‘censored’.  The median rate will be obtained from the Kaplan-Meier/Product-Limit Estimates and 
its corresponding 95% confidence interval will be computed, using Greenwood’s formula2 to 
calculate the standard error.   
 
Univariate analyses will be performed to screen for potential predictors of AF.  The chi-square test 
or Fisher’s exact test, as deemed appropriate, will be used to compare AF patients with non-AF 
patients for categorical variables and the two-sample t-test or Mann-Whitney test for continuous 
data. 
 
As a possible secondary analysis, those factors that appear to be associated with AF in the 
univariate analysis (p<0.25) will be included in a logistic regression model.  Backwards selection 
will be used to remove variables that do not significantly contribute information to the model, 
given other factors included in the model.  A receiver operating characteristic (ROC) curve will be 
constructed to look at the final model’s ability to predict AF.  A numerical measure of the accuracy 
of the model will be obtained from the area under the curve (AUC), where an area of 1.0 signifies 
near perfect accuracy, while an area of less than 0.5 indicates that the model is worse than just 
flipping a coin. The following will be used as a guide for AUC:  
0.9-1.0   Excellent 
0.8-0.9   Very good 
0.7-0.8   Good 
0.6-0.7   Average 
0.5-0.6   Poor  
The Hosmer and Lemeshow Goodness-of-Fit test will also be used to test how well the model fits 
the data.  
 
Unless otherwise specified, a result will be considered statistically significant at the p<0.05 level 
of significance.  All analyses will be performed using SAS (SAS Institute, Cary, NC). 
 
DISCOMFORTS AND RISKS 
The risks to the subjects are low in relation to the anticipated benefits of detecting paroxysmal AF, 
which will change the strategy of secondary stroke prevention from antiplatelet to anticoagulation 
                                               
1 Lee, E. T. (1992), Statistical Methods for Survival Data Analysis, Second Edition, New York: John Wiley & Sons. 
 
2 Greenwood M. (1926), The Errors of Sampling of the Survivorship Table, Vol. 33 of Reports on Public Health and Medical 
Subjects. London: Her Majesty's Stationery Office 
 

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therapy and reduce the annual risk of recurrent stroke by allowing earlier treatment once AF is 
detected. The procedural risks have been reviewed under the section (“Design: Reveal LINQ 
Insertable Cardiac Monitor) 
 
 
Potential risks and discomforts associated with receiving a Reveal LINQ ICM device include: 
• Local site bleeding 
• Temporary discomfort at the implant site. 
• Rejection of the device by the body, which may have symptoms such as swelling, 
redness, or other irritation at or near the implant site 
• Movement of the device from its original implant location 
• Allergy reactions to the device 
• Infection at the site of the implant 
• Cosmetic complications at the site of device placement 
• Inability of the device to capture some particular arrhythmias  
• Risks associated with local anesthesia, including hypersensitivity and allergic reactions 
to the anesthetic agent, injection site bleeding or infection 
 
POTENTIAL BENEFITS 
The presence of paroxysmal AF in non-cryptogenic stroke patients, who have a presumed stroke 
etiology other than AF, will help in identifying a stroke etiology that carries a high risk for 
recurrent stroke and will most likely result in a significant management adjustment in terms of 
long-term anticoagulation for secondary stroke prevention. It is well accepted that long-term 
anticoagulation of ischemic stroke and TIA patients with paroxysmal AF decreases the incidence 
of recurrent stroke. 
 
DISCONTINUATION OF STUDY/SUBJECT WITHDRAWAL 
Subjects have the right to withdraw from the study at any time without prejudice.  The site 
investigator may withdraw the subject from the study and remove the implantable device 
in the event of intercurrent illness, adverse events, other reasons concerning the health or well-
being of the subject, or in the case of lack of cooperation, non-compliance, protocol violation or 
other administrative reasons. Participants who regain decisional capacity and do not want the device in 
their body will also be withdrawn from the study and the implantable device will be removed. This will be 
discussed in detail during the enrollment and consenting process. 
 
DATA AND SAFETY MONITORING 
The Principal Investigator will be tasked with ensuring the data and safety of the study. This 
review will occur every 6 months after the first subject is enrolled. The PI, along designated co-
investigators, will review the incoming data to determine if aspects of the study need to be changed 
or stopped. In addition, they will review any and all deviations, adverse events and unanticipated 
problems that may occur to determine their relatedness to the study, their severity, and whether 
they require study changes. Adverse events include any device related complications or interval 
new medical conditions. Adverse events will be considered severe if they require hospitalization or 
are life threatening, or result from a malfunctioning of the study device. In addition, any 
unanticipated problems will be reported to the IRB and the LINQ manufacturer as per their 
specific reporting requirements. 
 
CONFIDENTIALITY 

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The data will be collected and stored on the “shared drive” that can be accessed by the 
investigators and research coordinators through a login and password on the NSLIJHS server. All 
PHI will be de-identified in the data set and will not be shared with any outside facility. 
 
FUNDING 
Funding for this research study is provided by Medtronic, Inc. The funding is used to support the 
activities of the Departments of Neurology and Cardiology to pay back the Departments for the 
costs of the study personnel. Medtronic may potentially donate up to 10 Reveal LINQ devices if 
the patient need arises. However, Medtronic is not donating all of the devices for this study. As the 
Reveal LINQ device is being used within its FDA indications, the charge for the device will be 
billed to the patient’s insurance carrier. 
 
REFERENCES:  
 
1. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for 
stroke: The Framingham Study. Stroke. 1991;22:983–988 
2. Hohnloser SH, Pajitnev D, Pogue J, et al. Incidence of stroke in paroxysmal versus 
sustained atrial fibrillation in patients taking oral anticoagulation or combined antiplatelet 
therapy: an ACTIVEWS substudy. J Am Coll Cardiol 2007; 50:2156–2161. 
3. Hart RG, Pearce LA, Rothbart RM, McAnulty JH,Asinger RW, Halperin JL. Stroke with 
intermittent atrial fibrillation: incidence and predictors during aspirin therapy: Stroke 
Prevention in Atrial Fibrillation Investigators. J Am Coll Cardiol 2000;35:183–187 
4. T. Rizos, A. Wagner, E. Jenetzky .Paroxysmal atrial fibrillation is more prevalent than 
persistent atrial fibrillation in acute stroke and transient ischemic attack patients. 
Cerebrovascular Diseases. 2011; 32(3):276–282. 
5. EMBRACE trial and SURPRISE study International Stroke Conference  2013 
(http://stroke.ahajournals.org/cgi/content/meeting_abstract/43/2_MeetingAbstracts/A153) 
6. Kamel H, Lees KR, Lyden PD, Teal PA, Shuaib A, Ali M, Johnston SC; Virtual 
International Stroke Trials Archive Investigators. Delayed detection of atrial fibrillation 
after ischemic stroke. J Stroke Cerebrovasc Dis. 2009 Nov-Dec;18(6):453-7 
7. Seet RCS, Friedman PA, Rabinstein AA. Prolonged rhythm monitoring fort he detection 
of occult paroxysmal atrial fibrillation in ischemic stroke of unknown cause. Circulation. 
2011; 124: 477– 486. 
8. Berstein R, Di Lazzaro V, Rymer MM, Diener HC, Sanna T, Brachmann J Passman RS, 
Morillo C, Thjis V, Rogers T, Beckers F, Lindborg K.  Cryptogenic Stroke and 
Underlying Atrial Fibrillation (CRYSTAL AF). 2014 International Stroke Conference; 
Late-Breaking Clinical. February 14, 2014. 
9. Hindricks G, Pokushalov E, Urban L, et al. Performance of a new leadless implantable 
cardiac monitor in detecting and quantifying atrial fibrillation—results of the XPECT trial. 
Circulation: Arrhythmia & Electrophysiology. 2010; 3:141-7. 
10. Khan M, and Miller, DJ. Detection of Paroxysmal Atrial Fibrillation in Stroke/TIA. Stroke 
Research and treatment.Volume 2013; Article ID 840265 

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11. Grond M, Jauss M, Hamann G, Stark E, Veltkamp R, Nabavi D, Horn M, Weimar C, 
Improved Detection of Silent Atrial Fibrillation Using 72-Hour Holter ECG in Patients 
With Ischemic Stroke A Prospective Multicenter Cohort Study. Neurology. 2010.May 
25;74(21):1666-70 
12. Kamel H, Hegde M, Johnson DR, Gage BF, Johnston SC. Cost effectiveness of outpatient 
cardiac monitoring to detect atrial fibrillation after ischemic stroke. Stroke. 2010;41:1514–
1520. 
13. Fuster V, Rydén LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA,et al; American 
College of Cardiology/American Heart Association Task. Circulation. 2006;114:e257–
e354 
 
 
 
 
 
 
 
 
 
 
 
 
APPENDICES: 
 

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Known AF +/- on 
Anticoagulation 
Pass 
Review Exclusion criteria 
Excluded from Study 
Informed Consent Obtained 
Ischemic Stroke Inpatient 
work up 
Possible Etiology 
per Trial of Org 
10172 in 
Acute Stroke 
T
t
t
Begin Enrollment process 
Implant device < 7 days of Stroke onset 
Cryptogenic Stroke 
   
No 
Yes