Ongoing - Clinical Form

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Indicate the patient's medical record number
Description

This number will not be shared with ICHOM. In the case patient-level data is submitted to ICHOM for benchmarking or research purposes, a separate ICHOM Patient Identifier will be created and cross-linking between the ICHOM Patient Identifier and the medical record number will only be known at the treating institution INCLUSION CRITERIA: All patients TIMING: On all forms REPORTING SOURCE: Administrative or clinical RESPONSE OPTIONS: According to institution

Data type

integer

Alias
UMLS CUI [1]
C1269815
Time Relative to Baseline
Description

This Item does not exist in the original standard set, instead it is asked to do the following: Please timestamp all variables. Some Standard Set variables are collected at multiple timepoints, and we will ask you to submit these variables in a concatenated VARIABLEID_TIMESTAMP form for future analyses. For example, VARIABLEID_AT (After treatment); VARIABLEID_AS (After surgery); VARIABLEID_UPDATE (Update at least annually), etc.

Data type

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1442488
Long-term consequences of disease
Description

Long-term consequences of disease

Alias
UMLS CUI-1
C0443252
UMLS CUI-2
C0686907
UMLS CUI-3
C0012634
Indicate if the patient has died
Description

Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1]
C0011065
Indicate the date of death
Description

Inclusion Criteria: If ‘1 = Yes’ to DEATH Timing: Ongoing Data Source: Administrative date Type: Date by DD/MM/YYYY Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1]
C1148348
DD/MM/YYYY
Tick if Date of death unknown
Description

Note: This item does not exist in the original version of the standard set. Please tick if you do not know the date of death. Inclusion Criteria: If ‘1 = Yes’ to DEATH Timing: Ongoing Data Source: Administrative date

Data type

boolean

Alias
UMLS CUI [1,1]
C1148348
UMLS CUI [1,2]
C0439673
Indicate cause of cardiovascular death
Description

Inclusion Criteria: If ‘1 = Yes’ to DEATH Timing: Ongoing Data Source: Administrative data Type: Single answer

Data type

integer

Alias
UMLS CUI [1]
C0007465
Indicate whether there was a cardiovascular event
Description

Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1]
C1320716
Indicate the type of cardiovascular event that occurred
Description

Inclusion Criteria: If ‘1 = Yes’ to CARDIOVASCULAREVENT Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0332307
Provide the date of which the Cardiovascular event occurred
Description

Inclusion Criteria: If ‘1, 2, or 3’ to EVENTTYPE Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0011008
DD/MM/YYYY
Indicate if a new clinical diagnosis of heart failure has been made in this patient
Description

Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205314
UMLS CUI [1,3]
C0332140
Provide the date of Heart failure diagnosis
Description

Inclusion Criteria: If ‘1 = Yes’ to HF Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0018801
UMLS CUI [1,3]
C0205314
UMLS CUI [1,4]
C0332140
DD/MM/YYYY
Indicate if left ventricular ejection fraction (LVEF) was measured
Description

Inclusion Criteria: If ‘1 = Yes’ to HF Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1]
C0428772
Provide date of LVEF measurement
Description

Inclusion Criteria: If ‘1 = Yes’ to LVEF Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0428772
DD/MM/YYYY
Provide a value of LVEF measurement
Description

Inclusion Criteria: If ‘1 = Yes’ to LVEF Timing: Ongoing Data Source: Clinical Type: Numerical value Response Options: LVEF measurement value

Data type

integer

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0242485
Indicate if the patient was admitted* due to an unplanned cardiovascular cause**
Description

Supporting Definition: * admission = at least one overnight stay at a hospital or acute care facility from first atrial fibrillation diagnosis **Cardiovascular causes for admission are ones in which the principal admitting diagnosis relates to the cardiovascular system: myocardial infarction / ischaemic heart disease, heart failure, stroke/TIA, peripheral arterial disease, AF, venous thromboembolism/PE, etc. Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C0038454
Indicate type of cardiovascular cause
Description

Inclusion Criteria: If ‘1 = Yes’ to CVHOSPADM Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0184666
UMLS CUI [1,3]
C0038454
UMLS CUI [1,4]
C0085978
Was a fast atrial arrhythmia detected?
Description

Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0085611
UMLS CUI [1,2]
C0456962
Provide the date when fast atrial arrhythmia was detected
Description

Inclusion Criteria: If ‘1 = Yes’ to FAA Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0085611
UMLS CUI [1,2]
C0456962
UMLS CUI [1,3]
C0011008
DD/MM/YYYY
Indicate type of treatment
Description

Inclusion Criteria: If ‘1 = Yes’ to FAA Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0085611
UMLS CUI [1,2]
C0456962
UMLS CUI [1,3]
C0087111
If the patient received the treatment, indicate the type of monitoring performed post-treatment
Description

Inclusion Criteria: If ‘1 = Yes’ to FAA Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0456962
UMLS CUI [1,2]
C0085611
UMLS CUI [1,3]
C0150496
UMLS CUI [1,4]
C2709088
Provide the date when each treatment started to be monitored
Description

Inclusion Criteria: If ‘1 = Yes’ to FAA Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2709088
UMLS CUI [1,3]
C0030695
UMLS CUI [1,4]
C0456962
UMLS CUI [1,5]
C0004238
DD/MM/YYYY
Was the patient free from fast atrial arrhythmia at the time of the post-treatment monitoring (i.e. in sinus rhythm or rate-controlled atrial fibrillation)?
Description

Inclusion Criteria: If ‘1 = Yes’ to FAA Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0456962
UMLS CUI [1,3]
C0085611
UMLS CUI [1,4]
C2709088
UMLS CUI [1,5]
C0030695
Complications of treatment
Description

Complications of treatment

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0009566
Indicate whether cardiovascular event was proven to be a haemorrhagic stroke
Description

Inclusion Criteria: If ‘1 = Yes’ to CVEVENT Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0333275
Please provide date of Haemorrhagic stroke
Description

Inclusion Criteria: If ‘1 = Yes’ to HSTROKE Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0038454
UMLS CUI [1,3]
C0333275
DD/MM/YYYY
Indicate whether the patient had fatal bleeding
Description

Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C1302234
UMLS CUI [1,2]
C0019080
Provide date of fatal bleeding event
Description

Inclusion Criteria: If ‘1 = Yes’ to FBLEED Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C0019080
DD/MM/YYYY
Indicate whether the patient had symptomatic bleeding in a critical area or organ e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, or pericardial, or intramuscular with compartment syndrome
Description

Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0231220
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C1511545
UMLS CUI [1,4]
C0205146
UMLS CUI [2,1]
C0231220
UMLS CUI [2,2]
C0019080
UMLS CUI [2,3]
C0178784
Provide date of symptomatic bleeding in a critical area or organ e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, or pericardial, or intramuscular with compartment syndrome
Description

Inclusion Criteria: If ‘1 = Yes’ to CRITICALBLEED Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0019080
UMLS CUI [1,4]
C1511545
UMLS CUI [1,5]
C0205146
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C0019080
UMLS CUI [2,4]
C0178784
DD/MM/YYYY
Indicate whether the patient had bleeding causing a fall in haemoglobin > 2g/dL or transfusion of > 2 units of whole blood/red cells
Description

Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0085639
UMLS CUI [1,4]
C0019046
UMLS CUI [2,1]
C0019080
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0686904
UMLS CUI [2,4]
C1879316
Provide date of when patient had bleeding causing a fall in haemoglobin > 2g/dL or transfusion of > 2 units of whole blood/red cells
Description

Inclusion Criteria: If ‘1 = Yes’ to BLEEDOUTCOME Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C0678227
UMLS CUI [1,4]
C0085639
UMLS CUI [1,5]
C0019046
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0019080
UMLS CUI [2,3]
C0678227
UMLS CUI [2,4]
C0686904
UMLS CUI [2,5]
C1879316
DD/MM/YYYY
Procedure
Description

Procedure

Alias
UMLS CUI-1
C0087111
Provide date of the procedure
Description

Inclusion Criteria: If ‘1-8’ to PROCEDURE Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1]
C2584899
DD/MM/YYYY
Did the patient receive one of the listed procedures? (choose the one that applies, note the patient could have several procedures)
Description

Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single or multiple answers

Data type

text

Alias
UMLS CUI [1]
C0455713
SAE
Description

SAE

Alias
UMLS CUI-1
C1519255
Did the patient experience serious adverse event(s) due to the procedure within 90 days of follow-up?
Description

Inclusion Criteria: If ‘1-8’ to PROCEDURE Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0184661
Provide date(s) of serious adverse events due to procedure
Description

Inclusion Criteria: If ‘1 = Yes’ to PROCEDURESAE Timing: Ongoing Data Source: Clinical Type: Date(s) Response Options: DD/MM/YYYY(s)

Data type

date

Measurement units
  • DD/MM/YYYY(s)
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0332282
UMLS CUI [1,4]
C0184661
DD/MM/YYYY(s)
Please specify serious adverse event(s)
Description

Inclusion Criteria: If ‘1 = Yes’ to PROCEDURESAE Timing: Ongoing Data Source: Clinical Type: Single/multiple answers

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0087111
Other SAE due to procedure, specification
Description

Note: This item does not exist in the original standard set. It can be filled in for specification if you ticked the item "SAE_10". Inclusion Criteria: If ‘1 = Yes’ to PROCEDURESAE Timing: Ongoing Data Source: Clinical Type: Free text

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0332282
UMLS CUI [1,4]
C0184661
UMLS CUI [1,5]
C2348235

Similar models

Ongoing - Clinical Form

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient ID
Item
Indicate the patient's medical record number
integer
C1269815 (UMLS CUI [1])
Time Relative to Baseline
Item
Time Relative to Baseline
text
C0439564 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item Group
Long-term consequences of disease
C0443252 (UMLS CUI-1)
C0686907 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
Item
Indicate if the patient has died
integer
C0011065 (UMLS CUI [1])
Code List
Indicate if the patient has died
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of death
Item
Indicate the date of death
date
C1148348 (UMLS CUI [1])
Date of death unknown
Item
Tick if Date of death unknown
boolean
C1148348 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Item
Indicate cause of cardiovascular death
integer
C0007465 (UMLS CUI [1])
Code List
Indicate cause of cardiovascular death
CL Item
an acute myocardial infarction (1)
C0155626 (UMLS CUI-1)
(Comment:en)
CL Item
sudden cardiac death (2)
C0085298 (UMLS CUI-1)
(Comment:en)
CL Item
heart failure (3)
C0018801 (UMLS CUI-1)
(Comment:en)
CL Item
stroke (4)
C0038454 (UMLS CUI-1)
(Comment:en)
CL Item
cardiovascular procedure (5)
C0189573 (UMLS CUI-1)
(Comment:en)
CL Item
cardiovascular haemorrhage (6)
C0007222 (UMLS CUI-1)
C0019080 (UMLS CUI-2)
(Comment:en)
CL Item
other cardiovascular causes e.g. peripheral arterial disease (7)
C0007465 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
C0007222 (UMLS CUI-3)
C1704436 (UMLS CUI-4)
(Comment:en)
CL Item
Non-cardiovascular death (8)
C0007465 (UMLS CUI-1)
C1298908 (UMLS CUI-2)
C0007222 (UMLS CUI-3)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate whether there was a cardiovascular event
integer
C1320716 (UMLS CUI [1])
Code List
Indicate whether there was a cardiovascular event
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Item
Indicate the type of cardiovascular event that occurred
integer
C0038454 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Indicate the type of cardiovascular event that occurred
CL Item
an ischaemic stroke (1)
C0948008 (UMLS CUI-1)
(Comment:en)
CL Item
a systemic embolism (2)
C0013922 (UMLS CUI-1)
C0205373 (UMLS CUI-2)
(Comment:en)
CL Item
an unclassified stroke (3)
C0038454 (UMLS CUI-1)
C1298908 (UMLS CUI-2)
C0008902 (UMLS CUI-3)
(Comment:en)
CL Item
none of above (4)
C0151453 (UMLS CUI-1)
(Comment:en)
Date of Cardiovascular event
Item
Provide the date of which the Cardiovascular event occurred
date
C1320716 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Indicate if a new clinical diagnosis of heart failure has been made in this patient
integer
C0018801 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0332140 (UMLS CUI [1,3])
Code List
Indicate if a new clinical diagnosis of heart failure has been made in this patient
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of a new heart failure diagnosis
Item
Provide the date of Heart failure diagnosis
date
C0011008 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0205314 (UMLS CUI [1,3])
C0332140 (UMLS CUI [1,4])
Item
Indicate if left ventricular ejection fraction (LVEF) was measured
integer
C0428772 (UMLS CUI [1])
Code List
Indicate if left ventricular ejection fraction (LVEF) was measured
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of Left ventricular ejection fraction
Item
Provide date of LVEF measurement
date
C0011008 (UMLS CUI [1,1])
C0428772 (UMLS CUI [1,2])
Value of LVEF measurement
Item
Provide a value of LVEF measurement
integer
C0428772 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Item
Indicate if the patient was admitted* due to an unplanned cardiovascular cause**
integer
C0184666 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
Code List
Indicate if the patient was admitted* due to an unplanned cardiovascular cause**
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Item
Indicate type of cardiovascular cause
integer
C0332307 (UMLS CUI [1,1])
C0184666 (UMLS CUI [1,2])
C0038454 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,4])
Code List
Indicate type of cardiovascular cause
CL Item
myocardial infarction / ischaemic heart disease (1)
C0027051 (UMLS CUI-1)
C1869045 (UMLS CUI-2)
(Comment:en)
CL Item
heart failure (2)
C0018801 (UMLS CUI-1)
(Comment:en)
CL Item
stroke/TIA (3)
C3844446 (UMLS CUI-1)
(Comment:en)
CL Item
peripheral arterial disease (4)
C1704436 (UMLS CUI-1)
(Comment:en)
CL Item
venous thromboembolism/PE (5)
C1861172 (UMLS CUI-1)
(Comment:en)
CL Item
atrial fibrillation (6)
C0004238 (UMLS CUI-1)
(Comment:en)
CL Item
other cardiovascular cause (7)
C0205394 (UMLS CUI-1)
C0007226 (UMLS CUI-2)
C0085978 (UMLS CUI-3)
(Comment:en)
Item
Was a fast atrial arrhythmia detected?
integer
C0085611 (UMLS CUI [1,1])
C0456962 (UMLS CUI [1,2])
Code List
Was a fast atrial arrhythmia detected?
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of fast atrial arrhythmia detection
Item
Provide the date when fast atrial arrhythmia was detected
date
C0085611 (UMLS CUI [1,1])
C0456962 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Indicate type of treatment
integer
C0085611 (UMLS CUI [1,1])
C0456962 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Code List
Indicate type of treatment
CL Item
Rate control drugs (1)
C0489879 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
(Comment:en)
CL Item
Pharmacological cardioversion (2)
C1963873 (UMLS CUI-1)
(Comment:en)
CL Item
Electrical cardioversion (3)
C0013778 (UMLS CUI-1)
(Comment:en)
CL Item
Atrial ablation (4)
C2825182 (UMLS CUI-1)
(Comment:en)
CL Item
AVN/His bundle ablation (5)
C3275044 (UMLS CUI-1)
C2007105 (UMLS CUI-2)
(Comment:en)
CL Item
Surgical atrial ablation (6)
C0547070 (UMLS CUI-1)
C0543467 (UMLS CUI-2)
(Comment:en)
CL Item
Pacemaker (7)
C0030163 (UMLS CUI-1)
(Comment:en)
CL Item
Other (8)
C0205394 (UMLS CUI-1)
(Comment:en)
Item
If the patient received the treatment, indicate the type of monitoring performed post-treatment
integer
C0456962 (UMLS CUI [1,1])
C0085611 (UMLS CUI [1,2])
C0150496 (UMLS CUI [1,3])
C2709088 (UMLS CUI [1,4])
Code List
If the patient received the treatment, indicate the type of monitoring performed post-treatment
CL Item
12-lead ECG (1)
C0430456 (UMLS CUI-1)
(Comment:en)
CL Item
Ambulatory monitoring (2)
C0439841 (UMLS CUI-1)
C0030695 (UMLS CUI-2)
(Comment:en)
CL Item
Implantable devices (3)
C0687659 (UMLS CUI-1)
(Comment:en)
CL Item
Wearable devices/smartphones (4)
C4505348 (UMLS CUI-1)
(Comment:en)
Date when each treatment started to be monitored
Item
Provide the date when each treatment started to be monitored
date
C0808070 (UMLS CUI [1,1])
C2709088 (UMLS CUI [1,2])
C0030695 (UMLS CUI [1,3])
C0456962 (UMLS CUI [1,4])
C0004238 (UMLS CUI [1,5])
Item
Was the patient free from fast atrial arrhythmia at the time of the post-treatment monitoring (i.e. in sinus rhythm or rate-controlled atrial fibrillation)?
integer
C1298908 (UMLS CUI [1,1])
C0456962 (UMLS CUI [1,2])
C0085611 (UMLS CUI [1,3])
C2709088 (UMLS CUI [1,4])
C0030695 (UMLS CUI [1,5])
Code List
Was the patient free from fast atrial arrhythmia at the time of the post-treatment monitoring (i.e. in sinus rhythm or rate-controlled atrial fibrillation)?
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Item Group
Complications of treatment
C0087111 (UMLS CUI-1)
C0009566 (UMLS CUI-2)
Item
Indicate whether cardiovascular event was proven to be a haemorrhagic stroke
integer
C0038454 (UMLS CUI [1,1])
C0333275 (UMLS CUI [1,2])
Code List
Indicate whether cardiovascular event was proven to be a haemorrhagic stroke
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of haemorrhagic stroke
Item
Please provide date of Haemorrhagic stroke
date
C0011008 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
C0333275 (UMLS CUI [1,3])
Item
Indicate whether the patient had fatal bleeding
integer
C1302234 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
Code List
Indicate whether the patient had fatal bleeding
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of fatal bleeding
Item
Provide date of fatal bleeding event
date
C0011008 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0019080 (UMLS CUI [1,3])
Item
Indicate whether the patient had symptomatic bleeding in a critical area or organ e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, or pericardial, or intramuscular with compartment syndrome
integer
C0231220 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C1511545 (UMLS CUI [1,3])
C0205146 (UMLS CUI [1,4])
C0231220 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C0178784 (UMLS CUI [2,3])
Code List
Indicate whether the patient had symptomatic bleeding in a critical area or organ e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, or pericardial, or intramuscular with compartment syndrome
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of symptomatic bleeding in a critical area or organ
Item
Provide date of symptomatic bleeding in a critical area or organ e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, or pericardial, or intramuscular with compartment syndrome
date
C0011008 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0019080 (UMLS CUI [1,3])
C1511545 (UMLS CUI [1,4])
C0205146 (UMLS CUI [1,5])
C0011008 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0019080 (UMLS CUI [2,3])
C0178784 (UMLS CUI [2,4])
Item
Indicate whether the patient had bleeding causing a fall in haemoglobin > 2g/dL or transfusion of > 2 units of whole blood/red cells
integer
C0019080 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0085639 (UMLS CUI [1,3])
C0019046 (UMLS CUI [1,4])
C0019080 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
C1879316 (UMLS CUI [2,4])
Code List
Indicate whether the patient had bleeding causing a fall in haemoglobin > 2g/dL or transfusion of > 2 units of whole blood/red cells
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of when bleeding caused a fall in haemoglobin or transfusion
Item
Provide date of when patient had bleeding causing a fall in haemoglobin > 2g/dL or transfusion of > 2 units of whole blood/red cells
date
C0011008 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C0085639 (UMLS CUI [1,4])
C0019046 (UMLS CUI [1,5])
C0011008 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C0678227 (UMLS CUI [2,3])
C0686904 (UMLS CUI [2,4])
C1879316 (UMLS CUI [2,5])
Item Group
Procedure
C0087111 (UMLS CUI-1)
Date of the procedure
Item
Provide date of the procedure
date
C2584899 (UMLS CUI [1])
Item
Did the patient receive one of the listed procedures? (choose the one that applies, note the patient could have several procedures)
text
C0455713 (UMLS CUI [1])
Code List
Did the patient receive one of the listed procedures? (choose the one that applies, note the patient could have several procedures)
CL Item
Catheter-based ablation (1)
C2702800 (UMLS CUI-1)
(Comment:en)
CL Item
Pulmonary vein isolation (1a)
C3544330 (UMLS CUI-1)
(Comment:en)
CL Item
Complex left atrial catheter ablation (1b)
C2702800 (UMLS CUI-1)
C0443246 (UMLS CUI-2)
(Comment:en)
CL Item
AV node ablation (1c)
C3275044 (UMLS CUI-1)
(Comment:en)
CL Item
Atrial flutter ablation (1d)
C2702801 (UMLS CUI-1)
(Comment:en)
CL Item
Surgical ablation procedure (including all types of maze procedures) (2)
C0547070 (UMLS CUI-1)
C0543467 (UMLS CUI-2)
C0397414 (UMLS CUI-3)
(Comment:en)
CL Item
Hybrid surgical-catheter ablation (3)
C0004238 (UMLS CUI-1)
C0009429 (UMLS CUI-2)
C0547070 (UMLS CUI-3)
C0543467 (UMLS CUI-4)
C0397414 (UMLS CUI-5)
C2702800 (UMLS CUI-6)
(Comment:en)
CL Item
Left atrial appendage closure/occlusion (device) (4)
C0004238 (UMLS CUI-1)
C0205091 (UMLS CUI-2)
C4523927 (UMLS CUI-3)
C0004238 (UMLS CUI-5)
C0205091 (UMLS CUI-6)
C0441597 (UMLS CUI-7)
(Comment:en)
CL Item
Left atrial appendage ligation/excision (surgical) (5)
C0004238 (UMLS CUI-1)
C0225860 (UMLS CUI-2)
C0598782 (UMLS CUI-3)
C0023690 (UMLS CUI-4)
C0004238 (UMLS CUI-5)
C0225860 (UMLS CUI-6)
C0598782 (UMLS CUI-7)
C0543467 (UMLS CUI-8)
C0728940 (UMLS CUI-9)
(Comment:en)
CL Item
Electrical cardioversion (6)
C0004238 (UMLS CUI-1)
C0013778 (UMLS CUI-2)
(Comment:en)
CL Item
Pacemaker implantation (7)
C0189842 (UMLS CUI-1)
(Comment:en)
CL Item
Pharmacological cardioversion (8)
C0004238 (UMLS CUI-1)
C1963873 (UMLS CUI-2)
(Comment:en)
CL Item
No, patient didn’t receive any of listed procedures (9)
C0087111 (UMLS CUI-1)
C4489286 (UMLS CUI-2)
(Comment:en)
Item Group
SAE
C1519255 (UMLS CUI-1)
Item
Did the patient experience serious adverse event(s) due to the procedure within 90 days of follow-up?
integer
C1519255 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
Code List
Did the patient experience serious adverse event(s) due to the procedure within 90 days of follow-up?
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date(s) of Serious adverse events due to procedure
Item
Provide date(s) of serious adverse events due to procedure
date
C0011008 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,4])
Item
Please specify serious adverse event(s)
text
C1519255 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Code List
Please specify serious adverse event(s)
CL Item
In hospital death (1)
C0277608 (UMLS CUI-1)
(Comment:en)
CL Item
Vascular complications (2)
C1393529 (UMLS CUI-1)
(Comment:en)
CL Item
Postoperative haemorrhage (2a)
C0032788 (UMLS CUI-1)
(Comment:en)
CL Item
Postoperative haemorrhage requiring transfusion (2b)
C0032788 (UMLS CUI-1)
C1514873 (UMLS CUI-2)
C1879316 (UMLS CUI-3)
(Comment:en)
CL Item
Vascular complications (2c)
C1393529 (UMLS CUI-1)
(Comment:en)
CL Item
Pericardial tamponade (2d)
C0007177 (UMLS CUI-1)
(Comment:en)
CL Item
Requiring open heart surgery (3)
C1514873 (UMLS CUI-1)
C0189745 (UMLS CUI-2)
(Comment:en)
CL Item
Requiring repeat ablation procedure (4)
C1514873 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
C0162563 (UMLS CUI-3)
(Comment:en)
CL Item
Ventricular arrhythmias (5)
C0085612 (UMLS CUI-1)
(Comment:en)
CL Item
Respiratory complications (6)
C0035237 (UMLS CUI-1)
C0009566 (UMLS CUI-2)
(Comment:en)
CL Item
Pneumothorax (6a)
C0032326 (UMLS CUI-1)
(Comment:en)
CL Item
Phrenic nerve palsy (6b)
C0238371 (UMLS CUI-1)
(Comment:en)
CL Item
Pulmonary vein stenosis (6c)
C0340756 (UMLS CUI-1)
(Comment:en)
CL Item
Other iatrogenic respiratory complications (6d)
C0205394 (UMLS CUI-1)
C0439669 (UMLS CUI-2)
C0035237 (UMLS CUI-3)
C0009566 (UMLS CUI-4)
(Comment:en)
CL Item
Trauma embolic complications, stroke, TIA, systemic or pulmonary embolism (7)
C3714660 (UMLS CUI-1)
C0013922 (UMLS CUI-2)
C0009566 (UMLS CUI-3)
C0038454 (UMLS CUI-5)
C0007787 (UMLS CUI-7)
C0205373 (UMLS CUI-9)
C0013922 (UMLS CUI-10)
C0034065 (UMLS CUI-12)
(Comment:en)
CL Item
Postprocedure infections (8)
C3714514 (UMLS CUI-1)
(Comment:en)
CL Item
Atrio-esophageal fistula (9)
C3854460 (UMLS CUI-1)
(Comment:en)
CL Item
Other (specify) (10)
C0205394 (UMLS CUI-1)
(Comment:en)
Other SAE due to procedure, specification
Item
Other SAE due to procedure, specification
text
C0205394 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])