ARRHYTHMIAS
Protocol Identifier
Subject Identifier
Visit Description
Treatment Period ABC
Visit XYZ
Upload the source documents for all data requested in this eCRF (e.g., labs, study results) as well as
the admission History and Physical Examination findings and the Discharge Summary.
CLINICAL PRESENTATION
Date and time of arrhythmic event
:
Hr:Min(00:00 - 23:59)
Day Month
Year
Did event include cardiac arrest?
(Y)
Yes
(N)
No
[NK]
Not Known
If yes, was CPR or shock delivered?
(Y)
Yes
(N)
No
[NK]
Not Known
[NK]
Not Known
No
No
No
No
No
[NK]
[NK]
[NK]
[NK]
[NK]
Not Known
Not Known
Not Known
Not Known
Not Known
Is there a family hx for unexplained sudden death or QT prolongation?
(Y)
Yes
(N)
No
[NK]
Not Known
What was heart rate at time of presentation?
beats/minute
PAST MEDICAL HISTORY
Did subject have a prior history of any of the following:
Arrhythmia?
(Y)
Cardiomyopathy?
(Y)
Syncope with exercise?
(Y)
ECG abnormality?
(Y)
QT prolongation?
(Y)
Yes
Yes
Yes
Yes
Yes
(N)
(N)
(N)
(N)
(N)
SYMPTOMS
Chest pain
(Y)
Yes
(N)
No
[NK]
Not Known
Syncope
(Y)
Yes
(N)
No
[NK]
Not Known
Presyncope
(Y)
Yes
(N)
No
[NK]
Not Known
Heart failure
If yes, complete Heart Failure eCRF
(Y)
Yes
(N)
No
[NK]
Not Known
Seizures
(Y)
Yes
(N)
No
[NK]
Not Known
Other
(Y)
Yes
(N)
No
[NK]
Not Known
___________________________________________
specify:
ECG STANDARD 12-LEAD
Was an ECG Performed?
(Y)
Yes
Page 1
(N)
No
[NK]
Not Known
ARRHYTHMIAS
Protocol Identifier
Subject Identifier
Visit Description
Treatment Period ABC
Visit XYZ
If Yes, date and time of ECG?
:
Day Month Year Hr:Min (00:00 – 23:59)
Upload available ECGs. If only one ECG slot available, insert ECG that best characterizes the arrhythmic
event.
Companies to consider adding ability to insert more ECGs as appropriate.
RHYTHM
 all that apply:
heart rate _______
beats/minute
[NK]
Not Known
Marked bradycardia (heart rate less than 40 beats/minute
Narrow QRS tachycardia (heart rate greater than 120 beats/minute)
First degree AV Block
Type 2 second degree AV block
Third degree AV block
Atrial flutter
Atrial fibrillation
acute
chronic
Ventricular tachycardia, sustained
Ventricular tachycardia, non-sustained
Ventricular fibrillation
Torsade de Pointes
QTc greater than 500 msec
Other abnormal rhythm,
Specify:___
If no ECG was performed, what was the clinical _____________________________________________
diagnosis of the arrhythmia(s)?
Page 2
ARRHYTHMIAS
Protocol Identifier
Subject Identifier
Visit Description
Treatment Period ABC
Visit XYZ
DIAGNOSTIC TRACING(S)
Is a rhythm / in-hospital telemetry strip available?
(Y)
Yes
(N)
No
[NK]
Not Known
If Yes, date and time of rhythm strip
:
Day Month Year
Hr:Min(00-00-23:59)
--------------------------------------------------------------------------------------------------------------------------------------------Is a pacemaker / ICD strip printout available?
(Y)
Yes
(N) No
[NK]
Not Known
If Yes, date and time of pacemaker/ICD strip
:
Day Month Year
Hr:Min(00-00-23:59)
--------------------------------------------------------------------------------------------------------------------------------------------Is a loop recorder printout available?
(Y)
Yes
(N) No
[NK]
Not Known
If Yes, date and time of loop recorder
:
Day Month Year
Hr:Min(00-00-23:59)
--------------------------------------------------------------------------------------------------------------------------------------------Is a Holter monitor report / printout available?
(Y)
Yes
(N) No
[NK]
Not Known
If Yes, date and time of Holter monitor
:
Day Month Year
Hr:Min(00-00-23:59)
-----------------------------------------------------------------------------------------------------------------------------------------------Is an Electrophysiology Study (EP) report available? (Y)
Yes
(N) No
[NK]
Not Known
If Yes, date and time of Electrophysiology study
:
Day Month Year
Hr:Min(00-00-23:59)
------------------------------------------------------------------------------------------------------------------------------------------------
LABORATORY RESULT DATA
Are there any relevant chemistry labs within
(Y)
Yes
(N) No
[NK]
Not Known
24 hours of event (before or after event)
If Yes, complete below:
Note: Enter ‘NR’ if the laboratory results are not available to report or if a lab error occurred.
Laboratory Name__________________________________________
Lab ID
Address_________________________________________________
________________________________________________________
Date
Time
Test
Result
Normal Ranges
Day Month Year
Hr: Min
00:00-23:59
e.g. 01 JAN 2012
13:25
Low High
Serum Creatinine
Potassium
Magnesium
Page 3
83
62
115
Unit
umol/l
ARRHYTHMIAS
Protocol Identifier
Subject Identifier
Visit Description
Treatment Period ABC
Visit XYZ
Calcium
Glucose
List all labs available. Add lines for serial values of the same lab as needed.
Are there thyroid function studies available?
(Y)
Yes
(N) No
[NK]
Not Known
(From within last year)
If Yes, complete below:
Note: Enter ‘NR’ if the laboratory results are not available to report or if a lab error occurred.
Laboratory Name__________________________________________
Lab ID
Address_________________________________________________
________________________________________________________
Date
Time
Test
Result
Normal Ranges
Day Month Year
e.g. 01 JAN 2012
Hr: Min
00:00-23:59
13:25
Serum Creatinine
83
Serum TSH
Serum total T4
concentration
Serum total T3
concentration
Serum free T4
concentration
Serum free T3
concentration
T3-resin uptake
List all labs available. Add lines for serial values of the same lab as needed.
Low
High
Unit
62
115
umol/l
ECHOCARDIOGRAPHY
Was an Echocardiogram performed?
[Y]
Yes
[N]
N
[NK]
Not Known
If Yes, complete the following:
Date and time of Echocardiogram:
Day
Ejection Fraction Assessment (systolic function)?
If Yes, record percentage
Evidence of diastolic dysfunction?
Month
[Y]
Yes
Year
[N]
Hrs:Mins
(00:00-23:59)
N
[NK]
Not Known
N
[NK]
Not Known
%
[Y]
Page 4
Yes
[N]
ARRHYTHMIAS
Protocol Identifier
Subject Identifier
Visit Description
Treatment Period ABC
Visit XYZ
Evidence of significant valvular disease?
[Y]
Evidence of cardiac dilatation?
Evidence of regional wall motion abnormality?
[Y]
Yes [N] N [NK]
Not Known
[A]
Atrial [V] Ventricular
[NK]
Not Known
[Y]
Yes [N] N [NK]
Not Known
Was a prior Echocardiogram performed?
[Y]
If Yes, indicate which chamber(s)
Yes
Yes
[N]
[N]
N
N
[NK]
[NK]
Not Known
Not Known
If Yes, complete the following:
Date and time of prior Echocardiogram:
Day
Prior Ejection Fraction Assessment (systolic
function)?
[Y]
Month
Yes
[N]
Year
Hrs:Mins
(00:00-23:59)
N
[NK]
Not Known
%
If Yes, record percentage
Prior evidence of diastolic dysfunction?
[Y]
Yes
[N]
N
[NK]
Not Known
Evidence of significant valvular disease?
[Y]
Yes
[N]
N
[NK]
Not Known
Evidence of cardiac dilatation?
[Y]
Yes [N] N [NK]
Not Known
[A]
Atrial [V] Ventricular
[NK]
Not Known
[Y]
Yes [N] N [NK]
Not Known
If Yes, indicate which chamber(s)
Evidence of regional wall motion abnormality?
MUGA
Was a Multiple Gated Acquisition Scan (MUGA)
performed?
[Y]
Yes
[N]
N
[NK]
Not Known
If Yes, complete the following:
Date and time of MUGA:
Day
Month
Page 5
Year
Hrs:Mins
(00:00-23:59)
ARRHYTHMIAS
Protocol Identifier
Subject Identifier
Visit Description
Treatment Period ABC
Visit XYZ
Ejection Fraction Assessment?
[Y]
Yes
[N]
N
[NK]
Not Known
%
If Yes, record percentage
Evidence of wall motion abnormalities?
Was a prior Multiple Gated Acquisition Scan
(MUGA) performed?
[Y]
Yes
[N]
N
[NK]
Not Known
[Y]
Yes
[N]
N
[NK]
Not Known
If Yes, complete the following:
Date and time of prior MUGA:
Day
[Y]
Prior Ejection Fraction Assessment?
Month
Yes
[N]
Year
Hrs:Mins
(00:00-23:59)
N
[NK]
Not Known
N
[NK]
Not Known
%
If Yes, record percentage
Evidence of wall motion abnormalities?
[Y]
Yes
[N]
HOSPITALIZATIONHOSPITALIZATION
Was subject hospitalized due to arrhythmias?
(Y)
Yes (N)
No
If Yes, admission date and time
Day
Month
(Y)
Yes
Year
[NK]
Not Known
:
Hr:Min(00-00-23:59)
THERAPY
Was any of the following therapy administered?
Cardioversion
Pharmacological
(N)
No
[NK]
Not Known
Supplemental: consider listing specific classes, acute / chronic pharmacotherapy to treat the arrhythmia
Electrical
Defibrillation
(Y)
Yes
(N)
No
[NK]
Not Known
(Y)
Yes
(N)
No
[NK]
Not Known
Page 6
ARRHYTHMIAS
Protocol Identifier
Subject Identifier
Visit Description
Treatment Period ABC
Visit XYZ
Defibrillator/pacemaker insertion
(Y)
Yes
(N)
No
[NK]
Not Known
Radiofrequency ablation
(Y)
Yes
(N)
No
[NK]
Not Known
Surgery (e.g., MAZE procedure)
(Y)
Yes
(N)
No
[NK]
Not Known
Any sequelae as a result of the arrhythmia?
If Yes, specify_______
(Y)
Yes
(N)
No
[NK]
Not Known
Page 7