Table 2

Prospective Data (Collected After Enrolling in Study)# †

ELEMENTDEFINITION
General
TypeType of encounter in healthcare facility:
of • Emergency admission for AF
encounter • Emergency admission for other cardiovascular problem
 • Emergency admission for noncardiovascular problem (e.g., pneumonia)
 • Planned admission for AF
 • Planned admission for cardiovascular disease
 • Planned admission for noncardiovascular disease
 • Regularly scheduled outpatient visit
 • Emergency room visit, not admitted
 • Other outpatient visit It may be useful to collect more specific information.
PrimaryPrimary symptom or condition that prompted patient to seek medical attention:
reason • AF related
for • Other cardiac-related reason
encounter • Not cardiac related
PatientClassify patient based on the episodes of AF within the past 12 months:
classification • First Detected: Patient with a first-detected episode lasting fewer than 6 months
of • Paroxysmal: Patient with history of 2 or more episodes of paroxysmal AF only
type • Persistent: Patient with history of 2 or more episodes of persistent AF only
of • Mixed Paroxysmal/Persistent: Patient with history of 2 or more episodes of AF of either paroxysmal or persistent type
AF • Permanent: Patient with history of 2 or more episodes of AF with at least 1 episode of permanent AF, or a first-detected episode lasting more than 6 months for which no attempt or further attempt to restore sinus rhythm is planned
episodes(See “Qualifying Rhythm” for definitions of episode classification.)
CurrentIndicate the types of strategies that are currently being employed. Indicate all that apply:
managementRate Control:
strategy • Pharmacological
 • Nonpharmacological
 • Hybrid#
Rhythm Control:
 • Pharmacological
 • Nonpharmacological
 • Hybrid$
$Hybridis defined as concurrent use of:
 • Pharmacological and nonpharmacological therapies or
 • Two or more nonpharmacological therapies.
Medications on Encounter
Antiarrhythmic drugs and rate-control agentsList generic names of all antiarrhythmic and rate-control medications (including beta-blockers, calcium-channel blockers, and digoxin) that are currently prescribed to patient. Indicate daily dose.
Antithrombotic agentsList generic names for all antithrombotic and antiplatelet medications (including aspirin and clopidogrel) that are currently prescribed to patient. Indicate daily dose.
Angiotensin-converting enzyme inhibitorsList generic names for all angiotensin-converting enzyme inhibitors that are currently prescribed to patient.
Angiotensin receptor blockersList generic names for all angiotensin receptor blockers that are currently prescribed to patient.
Other cardiac medicationsList generic names for all other cardiac medications that are currently prescribed to patient.
Thyroid replacementIndicate whether patient is currently receiving thyroxine and/or T3.
Antidiabetic therapyPatient has current prescription for antidiabetic medication. Indicate type:
 • Oral agent
 • Insulin
 • Both oral agent and insulin
Nonsteroidal anti-inflammatory drugs (NSAIDs),List NSAIDs taken on average more than once per week.
not including aspirin or(Note: This category does not include aspirin,
cyclooxygenase (Cox)-2 inhibitorsacetaminophen, or Cox-2 inhibitors.)
Cox-2 inhibitorList Cox-2 inhibitors taken on average more than once per week.
Beta-agonistsList inhaled and oral beta-2-adrenergic agonists taken on average more than once per week.
Physical Examination
Heart rateHeart rate (beats per minute) recorded closest to the time of presentation to the healthcare facility and/or on discharge (for inpatient). Heart rate may be ascertained from ECG tracing or from record of physical examination.
Systolic and diastolic blood pressureSystolic and diastolic blood pressure (mm Hg) recorded closest to the time of presentation to the healthcare facility. Patient position (supine, sitting, other) should be noted.
HeightPatient's height in centimeters or inches (list units)
WeightPatient's weight in kilograms or pounds (list units). Body mass index can be calculated from height and weight.
Physical signsIndicate whether patient meets criteria for congestive heart failure as defined by the Framingham Heart Study (19). A diagnosis of heart failure requires that 2 major criteria are present or that 1 major and 2 minor criteria are present concurrently.
signsMajor Criteriainclude:
and • Acute pulmonary edema
symtoms • Cardiomegaly
of • Increased venous pressure
congestive • Neck vein distension
heart • Positive hepatojugular reflex
failure • Inspiratory rales
 • S3 gallop
Minor Criteriainclude:
 • Dyspnea on exertion
 • Extremity edema
 • Hepatomegaly
 • Night cough
 • Pleural effusion
 • Tachycardia (more than 120 beats per minute)
PregnancyIndicate whether the patient is pregnant.
Laboratory Tests(include local reference ranges)
Thyroid • Serum thyroid-stimulating hormone level (μU/mL–micro units per milliliter)
function • Free T4 (local laboratory units)
tests • Total T3 (local laboratory units)
Serum creatinineSerum creatinine level (mg/dl or mmol/l)
Liver • Total bilirubin (g/dl)
function/ • Alkaline phosphatase (IU/dl)
assessment • Aspartate transaminase (AST) (U/dl)
 • Alanine transaminase (ALT) (U/dl)
 • Serum albumin (g/dl)
PotassiumSerum potassium (mg/dl or mmol/l)
MagnesiumSerum magnesium (mg/dl or mmol/l)
HemoglobinSerum hemoglobin (mg/dl)
International Normalized Ratio (INR)Measured INR for assessment of anticoagulation status/prothrombin time
GoalIndicate the listed goal INR for the patient
INR • 2.5 to 3.5
 • 2.0 to 3.0
 • Other (specify goal INR range and reason)
Partial thromboplastin time (PTT)Indicate whether activators used (aPTT) or not (PTT). Measured in seconds.
Electrocardiography
RhythmThe categories of rhythm are:
 • Sinus rhythm
 • Atrial fibrillation
 • Atrial flutter
 • Paced
 • Other rhythm (e.g., ventricular tachycardia, supraventricular tachycardia)
Heart rate on ECGHeart rate as measured on ECG. Recommended measurement is over at least 6 seconds.
Previous MIIndicate whether pathological Q waves are present on ECG.
LeftSpecify criteria. The following criteria have been validated prospectively in clinical studies:
ventricular • Sokolow-Lyon Voltage: S in V1+R V5 or V6 greater than 38 mm (does not require gender or age adjustment)
hypertrophy • Cornell Voltage: R avL+S V3 greater than 20 mm in females or 28 mm in males
 • Cornell Product: Cornell voltage times the QRS duration greater than 2440 (in females, 6 mm is added to their Cornell voltage)
CompleteSpecify whether any of the following are present, defined as QRS more than 120 milliseconds:
bundle-branch • Right bundle-branch block
block • Left bundle-branch block
 • Nonspecific intraventricular conduction delay
Pre-excitationIndicate whether characteristic delta wave is present.
Atrial abnormalityIndicate whether left, right, or biatrial abnormality is present.
U-wavesIndicate whether U-waves are present.
Corrected QT (QTc) intervalQTc interval measured from the ECG
Echocardiography
Echocardiographic modalityTransthoracic or transesophageal
Left atrial size—M-mode on echocardiographyLeft atrial size, using the “leading edge to leading edge” method, in centimeters, measured from M-mode in the parasternal long-axis view at end-ventricular systole.
Left atrial volume on echocardiographyOn two-dimensional imaging, using the left atrial areas traced in the four- and two-chamber views as calculated by the standardized methods (e.g., Simpson's method of disks) (20).
Left ventricular diastolic diameterLeft ventricular diameter measured at end ventricular diastole (in centimeters). Indicate whether by M-mode or two-dimensional imaging.
Left ventricular systolic functionSubjective assessment as:
 • Normal
 • Mildly decreased
 • Mild to moderately decreased
 • Moderately decreased
 • Moderately to severely decreased
 • Severely decreased
Ejection fractionNumber measured (specify technique) or estimated. Give midpoint if range given. Listed as a percentage.
Left ventricular diastolic functionCategories include:
 • Normal
 • Impaired relaxation (Grade I)
 • Pseudonormal (Grade II)
 • Restrictive, reversible (Grade III)
 • Restrictive, irreversible (Grade IV)
 • Not obtained
Left ventricular wall thicknessLeft ventricular end-diastolic thickness of septal and posterior walls as measured in the parasternal long-axis view (in centimeters). Indicate whether by M-mode or two-dimensional imaging.
Thrombus with location • Left atrial appendage
 • Left atrium
 • Right atrium
 • Left ventricle
 • Right ventricle
Indicate all that apply.
Spontaneous echo contrast with location • Left atrial appendage
 • Left atrium
 • Right atrium
 • Left ventricle
 • Right ventricle
Indicate all that apply.
Mitral valve morphologyPredominant assessment as:
 • Normal
 • Rheumatic
 • Myxomatous
 • Prolapsed
 • Flail
 • Prosthetic
 • Other abnormal, specify
Mitral stenosisMitral valve area estimated from the pressure half-time of the left ventricular inflow (220/pressure half-time)
Mitral regurgitation • None
 • Mild
 • Mild to moderate
 • Moderate
 • Moderate to severe
 • Severe
Other valvular diseaseList other valvular disease and severity.
Aortic plaque • Small (less than 1 mm)
 • Moderate (1 to 4 mm)
 • Large (greater than 4 mm)
 • Mobile
Brain Imaging
Head CT or MRIIndicate evidence of ischemic or hemorrhagic events on head CT or MRI. Also indicate other major abnormalities.
Quality of Life(See “General Considerations of the AF Clinical Data Standards” for a brief consideration of quality-of-life issues.)
Self-reported health statusAsk patient: “In general, compared to other people your age, would you say your health is…”:
 • Excellent
 • Very good
 • Good
 • Fair
 • Poor
Symptoms with prior episodes of AFFor each of (a) usual episode and (b) worst episode, symptoms as described by the patient as:
 • Minimal or no symptoms
 • Disabling
Summary Assessment
Heart failureNYHA class as reported by a physician (definitions adopted from NYHA without revision):
status: • Class I: Patients with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea.
New York Heart Association • Class II: Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, or dyspnea.
(NYHA) • Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.
classification • Class IV: Patients with cardiac disease resulting in inability to perform any physical activity without discomfort. Symptoms are present even at rest or on minimal exertion. If any physical activity is undertaken, shortness of breath is increased.
Angina statusCategory of patient's angina type if present (choose one):
 • Atypical chest pain: Pain, pressure, or discomfort in the chest, neck, or arms not clearly exertional or not otherwise consistent with pain or discomfort of myocardial ischemic origin.
 • Stable angina: Angina without a change in frequency or pattern for the 6 weeks before this procedure. Angina is controlled by rest and/or sublingual/oral/transdermal medications.
 • Unstable angina(one of the following criteria is necessary):
−Angina that occurred at rest and was prolonged, usually lasting more than 20 minutes
−New-onset angina of at least Canadian Cardiovascular Society (CCS) class III severity
−Recent acceleration of angina reflected by an increase in severity of at least 1 CCS class to at least CCS class III
 • Myocardial Infarction: For a complete definition, please refer to “Myocardial Infarction (MI)” in the “Other Events” section.
Angina class:Grading of patient's angina by class (CCS classification system) (21,22):
Canadian • Class I: Ordinary physical activity, such as walking or climbing stairs, does not cause angina. Angina occurs with strenuous, rapid, or prolonged exertion at work or recreation.
Cardiovascular • Class II: Slight limitation of ordinary activity. Angina occurs on walking or climbing stairs rapidly, walking uphill, walking or climbing stairs after meals, or in cold, in wind, or under emotional stress, or only during the few hours after awakening. Angina occurs on walking more than 2 blocks on the level and climbing more than 1 flight of ordinary stairs at a normal pace and in normal condition.
Society (CCS) • Class III: Marked limitations of ordinary physical activity. Angina occurs on walking 1 to 2 blocks on the level and climbing 1 flight of stairs in normal conditions and at a normal pace.
classification • Class IV: Inability to perform any physical activity without discomfort—anginal symptoms may be present at rest.
Cardioversion
SiteIndicate all that apply.
 • Transthoracic (single defibrillator)
 • Transthoracic (dual defibrillators)
 • Intracardiac/intravascular
 • Epicardial
WaveformCategories include:
 • Monophasic, all types
 • Rectilinear biphasic
 • Truncated exponential biphasic
 • Other, specify
Number of shocks deliveredIndicate the number of shocks delivered during current session.
Maximal energy usedIndicate maximal energy used in current session.
Medication for cardioversion attemptList generic name for medication used to attempt cardioversion for a patient from AF to normal sinus rhythm. Indicate route of administration (intravenous or oral) and total daily dose and units. (Include total dose until cardioversion or accepted failure.)
Success of cardioversion attemptAbsence of AF or atrial flutter for at least 10 seconds after shock delivery or at any time after antiarrhythmic drug administration. For pharmacological cardioversion, time frame for assessment will depend on medication and route of administration (e.g., success for intravenous ibutilide may be within 1 hour from the end of infusion, whereas success for oral amiodarone may be within several days).
Pattern of recurrenceAfter successful conversion:
 • Immediate recurrence of AF (returns in less than 2 minutes)
 • Subacute recurrence of AF (returns between 2 minutes and 14 days)
 • Late recurrence of AF (returns after 14 days)
Complications of conversionInclude all complications occurring from the initiation of cardioversion attempt to 28 days after cardioversion. Specify complication and categorize into:
 • Anesthesia related
 • Thromboembolic
 • Arrhythmic
 • Other
Nonpharmacological Therapy
Supraventricular ablationIndications (may have more than one):
 • Supraventricular tachycardia (e.g., AV node re-entry tachycardia, AV re-entry tachycardia, atrial tachycardia)
 • Atrial fibrillation
 • Atrial flutter
 • Other, specify
For AF/atrial flutter, indicate approach taken:
 • Focal (specify site)
 • Cavotricuspid isthmus
 • Other linear sites, specify
 • Atrioventricular node ablation plus permanent pacemaker Indicate energy source:
 • Radiofrequency
 • Cryoablation
 • Ultrasound
 • Laser
 • Other, specify
Pacemaker insertionSpecify type:
 • Single chamber (atrial)
 • Single chamber (ventricular)
 • Dual chamber (both atrial and ventricular, but not biventricular)
 • Biventricular of any type
Specify indication: (all that apply)
 • Sinus node dysfunction
 • AV block
 • Intraventricular (IV) block
 • Congestive heart failure
 • Atrial fibrillation with bradycardia
 • Atrial fibrillation without bradycardia
Specify whether capable of:
 • Pacing for prevention of atrial arrhythmias
 • Burst/antitachycardia pacing for tachycardia termination
Intracardiac defibrillator insertionSpecify type:
 • Single chamber
 • Dual chamber
 • Biventricular
Specify indication:
 • Atrial fibrillation
 • Secondary prevention of cardiac arrest
 • Primary prevention of cardiac arrest. High risk for ventricular tachycardia (e.g., hypertrophic cardiomyopathy, Brugada syndrome, long-QT syndrome)
 • Syncope with inducible ventricular tachycardia
Specify whether capability exists:
 • Burst pacing
 • Antitachycardia pacing
 • Cardioversion
Surgery/type • Maze:
−Approach: epicardial/endocardial
−Energy: radiofrequency ablation, cryoablation, laser, other
 • Other, specify
ComplicationsInclude all complications occurring from the initiation of nonpharmacological therapy to 28 days after nonpharmacological therapy. Specify complication and categorize into:
of • Anesthesia related
nonpharmacological • Thromboembolic
therapy • Arrhythmic
 • Procedural
 • Other
Thromboembolic Events
Ischemic strokeDocumented stroke or cerebrovascular accident consisting of acute loss of neurological function caused by an ischemic event with residual symptoms at least 24 hours after onset. The date of the most recent stroke should be noted. List most likely etiology:
 • Larger-artery disease (e.g., carotid)
 • Small-artery disease (lacunar)
 • Embolism
 • Not specified
Indicate whether confirmed by CT, MRI scan, or cerebral angiography.
Severity of strokeAssessed at approximately 3 months after event. Categories include:
 • Complete/near-complete recovery (able to return to prestroke level of function)
 • Mild to moderate deficit (deficits present, but patient can perform activities of daily living, such as dressing and feeding, with no or little assistance).
 • Severe deficit (required assistance to complete activities of daily living)
Transient ischemic attackAcute loss of neurological function caused by an ischemic event with resolution of symptoms by 24 hours after onset.
Non-central nervous system arterial embolic eventAbrupt vascular insufficiency associated with clinical and radiological evidence of arterial occlusion in a vascular bed other than the cerebrovascular system in the absence of other likely mechanisms (e.g., atherosclerosis). In the presence of peripheral arterial disease, diagnosis of embolism requires angiographic demonstration of abrupt arterial occlusion.
Hemorrhagic Events
Intracranial hemorrhageBleeding into or around the brain:
 • Hemorrhagic conversion of a primary ischemic stroke
 • Subarachnoid hemorrhage
 • Intracerebral hemorrhage
 • Other (including subdural and epidural hematomas)
 • Unknown
Indicate whether documented by CT or MRI.
Other hemorrhageBleeding is defined as either major or minor according to the following criteria:
 • Major: Leading to transfusion of at least 2 units of whole blood or erythrocytes, requiring hospitalization or surgery, resulting in permanent disability, or involving a critical anatomic site (retroperitoneal, pericardial, intraspinal, intracranial, atraumatic intra-articular, or intra-ocular bleeding associated with abrupt deterioration of visual acuity).
 • Clinically overt(but not major)
 • Occult(e.g., asymptomatic guaiac-positive stool) Include amount of hemoglobin drop and the time interval if data available.
TransfusionTransfusion of either whole blood or packed red blood cells due to a hemorrhagic event. Note the number of units transfused. Specify type (e.g., whole blood, packed erythrocytes, other blood products) and quantity (units or milliliters).
Procedural intervention to control bleedingIndicate type of procedural intervention (e.g., surgical or catheter-based) performed to control an episode of bleeding.
Adverse Drug or Device Event
Adverse drug or device eventAn adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product or a medical device and which does not have to have a causal relationship with this treatment. Information regarding an adverse event should include:
 • Generic name of drug or device associated with the event
 • Dose, if applicable
 • Cardiac: Subcategories of cardiac reactions include:
−Congestive heart failure
−Classic torsade de pointes
−Other sustained ventricular tachycardia or fibrillation
−Supraventricular tachycardia
−Mobitz type II or third-degree AV node block
−Mobitz type I or first-degree AV heart block
−Sinus bradycardia
−Other cardiac. Briefly specify
 • Noncardiac, specify
 • Severity. A serious adverse eventis defined as one that satisfies any of the following criteria:
−Results in death
−Is life-threatening (NOTE: The term “life-threatening” in the definition of “serious” refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death if it were more severe.)
−Requires inpatient hospitalization or prolongation of existing hospitalization
−Results in persistent or significant disability or incapacity
−Is a congenital abnormality or birth defect
 • Nonserious Event
 • Causality: Relationship of adverse event to the drug as determined by the judgment of the investigator:
−Definite
−Probable
−Possible
 • Action Taken:
−Drug or device permanently stopped
−Dose reduced or device changed
−Drug or device temporarily stopped
−Drug dosage or device not changed
Resource Utilization
Hospital admissionOfficial admission to a hospital or other acute healthcare facility. Include dates of admission and discharge.
Primary reason for admissionPrimary diagnosis of the event that prompted admission, as determined by the judgment of the investigator, given as text description and latest ICD code (e.g., ICD-9 or ICD-10). May be the same as principal discharge diagnosis.
Number of days in intensive careNumber of days in intensive care
Principal discharge diagnosisPrincipal discharge diagnosis listed in official record (e.g., used for reimbursement), given as text description and latest ICD code (e.g., ICD-9 or ICD-10)
Emergency department visitInclude visits not resulting in hospitalization.
Procedures performedIn addition to the procedure information obtained elsewhere in the data set (e.g., ECG, ablation, cardioversion, pacemaker/implantable cardioverter-defibrillator implant, echocardiography), other important procedures to document utilization include:
 • Chest X-ray
 • Exercise test (list imaging techniques if performed)
 • Holter monitor
 • Electrophysiology study
 • Angiography
 • Percutaneous intervention
 • Bypass surgery
 • Valve repair/replacement
Specialty of principal providerIndicate specialty of any provider substantially involved with decision making for encounter. Indicate all that apply:
 • Electrophysiologist
 • Cardiologist (nonelectrophysiologist)
 • Internist (noncardiologist)
 • Family physician
 • Other, specify
Other Events
Myocardial infarctionEither one of the following criteria satisfies the diagnosis for an acute, evolving, or recent MI:
 • Typical rise and gradual fall (troponin) or more rapid rise and fall (creatine kinase–MB) of biochemical markers of myocardial necrosis with at least 1 of the following:
−Ischemic symptoms
−Development of pathological Q waves on the ECG
−ECG changes indicative of ischemia (ST-segment elevation or depression)
−Coronary artery intervention (e.g., coronary angioplasty) preceding enzyme rise
Or
 • Pathological findings of an acute MI
In addition, indicate whether the MI is:
 • ST-elevation MI
 • Non–ST-elevation MI
 • Based on presence of complete left bundle-branch block or uncertain
DeathDeath includes all deaths regardless of etiology. Specify location
 • Hospital
 • Other institution
 • Community (includes home)
Cause of deathPrimary cause of death as determined by investigator:
 • Cardiovascular death indicates cause of death was sudden cardiac death, MI, unstable angina, or other coronary artery disease; vascular death (e.g., stroke, arterial embolism, pulmonary embolism, ruptured aortic aneurysm, or dissection); congestive heart failure; or cardiac arrhythmia. Consider further specifications, such as:
minus;Myocardial infarction
−Ischemic stroke
−Primary arrhythmic death (without MI)
−Progressive heart failure
−Intracranial hemorrhage
−Non–intracranial hemorrhage-related death
−Unexplained sudden death
−Other cardiovascular, specify
 • Noncardiovascular death, specify
 • Unknown/unable to categorize
  • # Note: Each element may be collected multiple times during clinical follow-up.

  • Boldfaced typeindicates elements of particular relevance to atrial fibrillation (AF).