Table 1

Retrospective and Concurrent Data (Collected at or Near the Time of Study Initiation)*

ELEMENTDEFINITION
Patient Demographics
Registry or study identifierUnique encrypted numeric identifier (unrelated to subject's personal identifying information) to enhance comparisons across studies while protecting patient privacy
Date of study entryDate of initiation of collection of information for study purposes
Date of birthPatient date of birth (day, month, and year of patient's birth)
GenderIndicate the patient's gender at birth. Choose one of the following:
 • Male
 • Female
Hispanic ethnicityIs this patient Spanish, Hispanic, or Latino? Choose one of the following:
 • Yes
 • No
RacePatient's race as determined by the patient/family:
 • American Indian or Alaska Native
 • Asian
 • Black or African American
 • Native Hawaiian or other Pacific Islander
 • White
 • Other
 • Unknown
Insurance payerIndicate the patient's primary insurance payer for this admission. Choose one of the following:
 • Government: Refers to patients who are covered by government-reimbursed care. In the U.S., this includes Medicare, Medicaid (including all state or federal Medicaid-type programs), Champus, and the Veteran's Administration health plan.
 • Commercial: Refers to all indemnity (fee-for-service) carriers and preferred provider organizations (PPOs).
 • HMO: Refers to a health maintenance organization characterized by coverage that provides healthcare services for members on a prepaid basis.
 • None: Refers to individuals with no or limited health insurance; thus, the individual is the payer regardless of ability to pay. Only mark “None” when “self” or “none” is denoted as the first insurance in the medical record.
 • Non-U.S. Insurance: Refers to individuals who reside in and have health insurance in another country.
Government payer typeIf the patient's primary insurance payer for this encounter is “Government,” choose the type of government insurance:
 • Medicare
 • Medicaid
 • Other
EducationIndicate the highest degree the patient has received. Categories include (recommend listing years of schooling if degrees do not apply to a specific population):
 • Less than high school graduate (fewer than 12 years)
 • High school graduate or equivalent (12 years)
 • Some college (more than 12 but fewer than 16 years)
 • Bachelor's degree (16 years)
 • Master's degree or higher degree (more than 16 years)
Patient Category
Qualifying cardiac rhythmRhythm recorded that qualified the person for the study:
 • First-detected AF
 • Paroxysmal AF: AF is self-terminating within 7 days of recognized onset
 • Persistent AF: AF is not self-terminating within 7 days or is terminated electrically or pharmacologically
 • Permanent AF: Cardioversion failed or not attempted
Predominant cardiac diagnosisExclusive categories include:
 • Mitral stenosis, with or without regurgitation
 • Coronary artery disease, with or without left ventricular dysfunction (prior documented myocardial infarction, angina, coronary revascularization, or stenosis on angiography greater than or equal to 50%)
 • Other structural heart disease, including nonischemic left ventricular systolic dysfunction (left ventricular ejection fraction less than 40% or fractional shortening less than 25%), moderate or severe valvular heart disease, asymmetrical left ventricular hypertrophy, and congenital heart disease. Exclude concentric left ventricular hypertrophy.
 • Hypertension, with or without left ventricular hypertrophy
 • No underlying structural or functional heart disease or hypertension
Atrial fibrillation due to transient or reversible causeIndicate whether the qualifying AF is due to a transient or reversible cause. Indicate all that apply:
 • Postoperative from cardiac surgery
 • Postoperative from noncardiac thoracic surgery
 • Postoperative from noncardic, nonthoracic surgery
 • Pericarditis
 • Lung disease
 • Hyperthyroidism
 • Other, specify
Prior Atrial Fibrillation
Previously used therapeutic strategiesIndicate the types of therapeutic strategies that have been employed previously. Indicate all that apply. (Note: One therapy may apply to more than one category, e.g., amiodarone may be used for rate and rhythm control.)
Rate Control:
 • Pharmacological
 • Nonpharmacological
 • Hybrid$
 • None
Rhythm Control:
 • Pharmacological
 • Nonpharmacological
 •
Hybrid*
 • None
*Hybridis defined as concurrent use of:
 • Pharmacological and nonpharmacological therapies or
 • 2 or more nonpharmacological therapies
Frequency of prior symptomatic episodesPatient estimate of average interval between symptomatic episodes in days
Duration of prior symptomatic episodesPatient estimate of duration of each of longest, shortest, and usual symptomatic episodes:
 • Less than 48 hours
 • 48 hours to 7 days
 • 7 days to 3 months
 • Longer than 3 months
If more specific short-term intervals are desired, recommend dividing the first category (less than 48 hours) into the following: less than 5 minutes, 5 minutes to less than 6 hours, 6 hours to less than 48 hours.
Successful prior pharmacological cardioversionList all generic drug names previously used that resulted in the absence of AF or atrial flutter.
Unsuccessful prior pharmacological cardioversion attemptedList all generic drug names previously used that did not result in the absence of AF or atrial flutter.
Successful prior transthoracic electrical cardioversionNumber of previous transthoracic electrical cardioversion sessions attempted that resulted in the absence of AF or atrial flutter. A session may include multiple successive shocks.
Unsuccessful prior transthoracic electrical cardioversion attemptedNumber of previous transthoracic electrical cardioversion sessions attempted that did not result in the absence of AF or atrial flutter. A session may include multiple successive shocks.
Successful prior transvenous electrical cardioversionNumber of previous transvenous electrical cardioversion sessions attempted that resulted in the absence of AF or atrial flutter. A session may include multiple successive shocks.
Unsuccessful prior transvenous electrical cardioversion attemptedNumber of previous transvenous electrical cardioversion sessions attempted that did not result in the absence of AF or atrial flutter. A session may include multiple successive shocks.
History of ablation for supraventricular arrhythmiaDocumented history of ablation for supraventricular arrhythmia. Indications (may have more than one):
 • Supraventricular tachycardia (e.g., atrioventricular node re-entry tachycardia, atrioventricular re-entry tachycardia)
 • AF
 • Atrial flutter
 • Atrial tachycardia
 • Other, specify
For AF/atrial flutter, indicate approach taken:
 • Focal (specify site)
 • Cavotricuspid isthmus
 • Other linear sites, specify
 • AV node ablation plus permanent pacemaker
Indicate energy source:
 • Radiofrequency
 • Cryoablation
 • Ultrasound
 • Laser
 • Other, specify
Thromboembolic History
History of ischemic strokeDocumented history of stroke or cerebrovascular accident with acute loss of neurological function caused by an ischemic or hemorrhagic event with residual symptoms at least 24 hours after onset.
List most likely etiology:
 • Larger-artery disease (e.g., carotid)
 • Small-artery disease (lacunar)
 • Embolism
 • Other, specify
 • Not specified
Indicate whether confirmed by CT, MRI scan, or cerebral angiography.
Residual deficit from prior strokeAssessed via current level of functioning. 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)
History of transient ischemic attackDocumented history of transient ischemic attack (TIA) consisting of acute loss of neurological function caused by an ischemic event with resolution of symptoms by 24 hours after onset.
History of systemic peripheral embolismDocumented history of abrupt vascular insufficiency associated with clinical and radiological or pathological evidence of arterial occlusion in a vascular bed other than the cerebrovascular system in the absence of other likely mechanisms (e.g., atherosclerosis). Indicate site.
History of carotid artery diseaseHistory of carotid artery disease with 50% or more stenosis. Indicate all modalities of assessment:
 • Ultrasound
 • Magnetic resonance angiography
 • Angiography
Hemorrhagic History
History of intracranial hemorrhageHistory of any prior bleeding into or around the brain. Categories include:
 • 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
Residual deficit from prior intracranial hemorrhageAssessed via current level of functioning. 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 (requires assistance to complete activities of daily living)
History of other hemorrhageHistory of bleeding 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.
Other Cardiovascular History
History of hypertensionIndicate whether the patient has hypertension as documented by:
 • History of hypertension diagnosed and treated with medication, diet, and/or exercise
 • Blood pressure greater than or equal to 140 mm Hg systolic or 90 mm Hg diastolic on at least 2 occasions
 • Currently undergoing antihypertensive pharmacological therapy More than one of the above may apply. The year of onset (first diagnosis) may be helpful.
History of heart failurePhysician documentation or report of any of the following symptoms of heart failure before this care encounter, described as dyspnea, fluid retention, or low cardiac output secondary to cardiac dysfunction; or the description of rales, jugular venous distension, or pulmonary edema. A previous hospital admission with principal diagnosis of heart failure is considered evidence of heart failure history.
History of valvular heart diseaseDocumented history of moderate or severe stenosis or regurgitation. Indicate stenosis or regurgitation for each valve involved. Date of onset (first diagnosis) may be helpful.
History of valve interventionIndicate each valve repair, valvuloplasty, or valve replacement in patient history. For valve replacement, indicate location and type.
History of myocardial infarction (MI)Previous MI before this encounter as determined by the following (indicate all that apply):
 • Hospital admission for acute MI
 • Electrocardiogram (ECG) report indicating previous (old) or acute MI
 • Increase in biochemical marker (e.g., creatine kinase or troponin) consistent with MI
 • Patient reports history of acute MI or heart attack
Date of the first and the most recent episodes may be helpful.
History of other coronary artery diseaseIndicate whether there is a documented history of any of the following:
 • Prior coronary artery bypass surgery (CABG)
 • Prior percutaneous coronary intervention (PCI)
 • Angiographically documented coronary artery stenosis greater than or equal to 50%
 • Positive stress test; specify imaging modality if performed
 • Angina pectoris
History of hypertrophic cardiomyopathyEchocardiographically established hypertrophic cardiomyopathy. Specify type:
 • Obstructive
 • Nonobstructive, nonhypertensive
Does not include hypertensive cardiomyopathy (concentric hypertrophy).
History of cardiomyopathyLeft ventricular systolic dysfunction with an estimated ejection fraction less than 0.40.
History of congenital heart diseaseCardiac anomaly present from birth or congenital abnormality on echocardiography. Specify diagnosis and any prior repair.
History of ventricular arrhythmiasVentricular tachycardia or ventricular fibrillation requiring cardioversion and/or medication (intravenous or oral) with antiarrhythmic drugs.
History of sinus bradycardia/sick sinus syndromeSymptoms due to sinus node dysfunction and manifested by the following (indicate all that apply):
 • Sinus bradycardia: Sinus rate 40 to 50 bpm with normal P-wave axis and PR interval
 • Severe sinus bradycardia: Sinus rate less than 40 bpm with normal P-wave axis and PR interval
 • Sinus arrest: Sudden absence of sinus activity
 • Sinoatrial exit block: Loss of sinus activity at an interval fixed to that of the basic P-P interval
 • Tachycardia-bradycardia syndrome: Paroxysmal tachycardias followed by bradycardia upon termination
History of atrioventricular (AV) blockHighest degree of block in past history:
 • 1st Degree:P-R interval greater than 200 ms
 • 2nd Degree:
−Mobitz I (Wenckebach): gradual PR prolongation until AV block
−Mobitz II: fixed PR interval until AV block
−Advanced AV block (e.g., 2:1, 3:1)
 • 3rd Degree(complete heart block): independent atrial and ventricular activity with an atrial rate faster than the ventricular rate
History of supraventricular tachycardiaIndicate any documented history of:
 • Atrial tachycardias
 • AV nodal re-entrant tachycardias
 • Orthodromic re-entrant tachycardias utilizing a concealed accessory bypass tract
 • Other supraventricular tachycardias, including undifferentiated re-entrant tachycardias; specify
History of ablation for other than AF or atrial flutterSpecify indication, which may include:
 • Wolff-Parkinson-White syndrome (manifest accessory AV connection)
 • AV nodal re-entrant tachycardias
 • Concealed accessory bypass tracts
 • Atrial tachycardias
 • Ventricular tachycardia
History of pacemaker insertionIndicate whether the patient has or has had a pacemaker inserted. If yes:
Specify 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
 • Congestive heart failure
 • Atrial fibrillation
Specify if capable of:
 • Burst pacing
 • Antitachycardia pacing
History of intracardiac defibrillator insertionIndicate whether the patient has or has had an intracardiac defibrillator inserted.
If yes:
Specify type:
 • Single-chamber pacing and shock therapies; specify chamber
 • Dual-chamber pacing and shock therapies
 • Atrial pacing with ventricular pacing and shock therapies
 • Ventricular shock and biventricular pacing therapies
Specify indication:
 • Atrial fibrillation
 • Secondary prevention of cardiac arrest
 • Primary prevention of cardiac arrest. High risk for ventricular tachycardia (e.g., ischemic heart disease, hypertrophic cardiomyopathy, Brugada syndrome, long-QT syndrome, arrhythmogenic right ventricular cardiomyopathy)
 • Syncope with inducible ventricular tachycardia
 • Unexplained syncope
Specify if capability exists:
 • Burst pacing
 • Antitachycardia pacing
 • Cardioversion
Other Medical History
History of diabetes mellitusHistory of diabetes, regardless of duration of disease, need for antidiabetic agents, or a fasting blood sugar greater than or equal to 7 mmol/l or 126 mg/dl. The year of onset (first diagnosis) may be helpful.
Diabetes control historyMethod of diabetic control at time of encounter. Choose one of the following:
 • None: No treatment for diabetes
 • Diet: Diet treatment
 • Oral: Oral agent treatment
 • Insulin: Insulin treatment
 • Insulin and oral: Insulin and oral agent treatment
History of chronic lung diseaseDocumented history of chronic lung disease (e.g., chronic obstructive pulmonary disease, chronic bronchitis) or currently being chronically treated with inhaled or oral pharmacological therapy (e.g., beta-adrenergic agonist, anti-inflammatory agent, leukotriene receptor antagonist, or steroid) for the indication of lung disease. Date of onset (first diagnosis) may be helpful.
History of thyroid diseaseHistory of hyperthyroidism or hypothyroidism. Indicate history of prior radioactive iodine treatment or prior medical treatment for hyperthyroidism.
History of chronic kidney diseaseStages are determined by measured or estimated glomerular filtration rate:
 • None: Greater than or equal to 90 mL/min/1.73 m2without kidney damage (e.g., proteinuria)
 • Stage I: Greater than or equal to 90 mL/min/1.73 m2with kidney damage (e.g., proteinuria)
 • Stage II: 60 to 89 mL/min/1.73 m2
 • Stage III: 30 to 59 mL/min/1.73 m2
 • Stage IV: 15 to 29 mL/min/1.73 m2
 • Stage V: Less than 15 mL/min/1.73 m2or on maintenance dialysis
History of chronic liver diseaseDocumented cirrhosis or chronic liver disease
Habits/Substance Abuse
History of alcohol consumption/dependencyAlcohol consumption history:
 • None
 • One or fewer alcoholic drinks per week
 • 2 to 7 alcoholic drinks per week
 • 8 to 14 alcoholic drinks per week
 • 15 or more alcoholic drinks per week
Alcohol dependency history:
 • Documented alcohol dependence
 • Medical sequelae of alcohol consumption (alcoholic hepatitis, cirrhosis, alcohol neuropathy, Wernicke-Korsakoff syndrome)
 • Treatment for alcohol dependency
For dependent consumers of alcohol, note treatment for dependency, cessation of use, or continued use.
History of smokingHistory confirming cigarette smoking in the past. Choose from the following categories:
 • Current: Smoking cigarettes within 1 month of this encounter
 • Recent: Stopped smoking cigarettes between 1 month and 1 year before this encounter
 • Former: Stopped smoking cigarettes more than 1 year before this encounter
 • Never: Never smoked cigarettes
For current or former smokers, total pack-years may be useful.
History of illicit drug useDocumented history of current, recent, or remote abuse of any controlled substance. Indicate substance.
Past Medications
Past antiarrhythmic drugs and rate-control agentsList generic names of all prior medications for rate and rhythm control. For each antiarrhythmic and rate-control medication used in the past (above), indicate the primary reason for discontinuation:
 • Ineffective
 • Not tolerated, specify
 • Other, specify
Past antithrombotic medicationsList generic names for all anticoagulation and antiplatelet medications (including aspirin and clopidogrel) used in the past. For each antithrombotic medication used in past (above), indicate the primary reason for discontinuation:
 • Ineffective
 • Not tolerated, specify
 • Other, specify
Past contraindication to antithrombotic therapyHas patient been considered for antithrombotic therapy in the past but not treated due to a contraindication? If yes, list contraindication.
  • * Boldfaced typeindicates elements of particular relevance to atrial fibrillation (AF).

  • $ Hybrid is defined as concurrent use of: (i) pharmacoclogical and non-pharmacological therapies or (ii) 2 or more non-pharmacological therapies.