ID

31483

Beschrijving

Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT01014741

Link

https://clinicaltrials.gov/show/NCT01014741

Trefwoorden

  1. 27-08-18 27-08-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

27 augustus 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Persistent Atrial Fibrillation NCT01014741

Eligibility Persistent Atrial Fibrillation NCT01014741

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females will be enrolled in the study.
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
age >18
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
referred for a first ever ablation procedure for symptomatic persistent/permanent af (only prior ablation of right-sided typical flutter is permitted)
Beschrijving

Ablation First Persistent atrial fibrillation Symptomatic | Ablation First Permanent atrial fibrillation Symptomatic | Ablation Atrial Flutter Right sided

Datatype

boolean

Alias
UMLS CUI [1,1]
C0547070
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C2585653
UMLS CUI [1,4]
C0231220
UMLS CUI [2,1]
C0547070
UMLS CUI [2,2]
C0205435
UMLS CUI [2,3]
C2586056
UMLS CUI [2,4]
C0231220
UMLS CUI [3,1]
C0547070
UMLS CUI [3,2]
C0004239
UMLS CUI [3,3]
C0444532
all patients must understand the requirements of the study and be willing to comply with the post study follow-up requirements.
Beschrijving

Comprehension Study Protocol | Compliance behavior Follow-up

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C3274571
patients must be in atrial fibrillation on the day of the procedure
Beschrijving

Atrial Fibrillation

Datatype

boolean

Alias
UMLS CUI [1]
C0004238
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any reversible cause of af (post-surgery, thyroid disorder, etc.)
Beschrijving

Cause Reversible Atrial Fibrillation | Status post Operative Surgical Procedures | Thyroid Diseases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0205343
UMLS CUI [1,3]
C0004238
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0543467
UMLS CUI [3]
C0040128
patients with a myocardial infarction or unstable angina in the previous 2 months.
Beschrijving

Myocardial Infarction | Angina, Unstable

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
patients with a history of rheumatic heart disease
Beschrijving

Rheumatic Heart Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0035439
patients with congenital heart disease
Beschrijving

Congenital heart disease

Datatype

boolean

Alias
UMLS CUI [1]
C0152021
patients with a history of hypertrophic cardiomyopathy
Beschrijving

Hypertrophic Cardiomyopathy

Datatype

boolean

Alias
UMLS CUI [1]
C0007194
patients with lv ejection fraction < 35%
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
class iv congestive heart failure
Beschrijving

Congestive heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
patients who have experienced any cerebral ischemic event, including any tia in the preceding 1 month.
Beschrijving

Cerebral Ischemia | Transient Ischemic Attack

Datatype

boolean

Alias
UMLS CUI [1]
C0917798
UMLS CUI [2]
C0007787
women who are known to be pregnant or have had a positive β-hcg test 7 days prior to procedure.
Beschrijving

Pregnancy | Serum Beta-HCG Test Positive

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C1255526
UMLS CUI [2,2]
C1514241
patients with any other significant uncontrolled or unstable medical condition (including uncontrolled clinically significant coagulation disorders).
Beschrijving

Other medical condition Uncontrolled | Other medical condition Unstable | Blood Coagulation Disorders Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0005779
UMLS CUI [3,2]
C0205318
patients whose life expectancy is less than one year.
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
history of malignant ventricular arrhythmias or long qt interval (>500msec)
Beschrijving

Malignant ventricular arrhythmias | Prolonged QT interval

Datatype

boolean

Alias
UMLS CUI [1]
C0857380
UMLS CUI [2]
C0151878
prior left-sided cardiac ablation procedure (catheter based or surgical)
Beschrijving

Cardiac ablation Left sided Catheter | Cardiac ablation Left sided Surgical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162563
UMLS CUI [1,2]
C0443246
UMLS CUI [1,3]
C0085590
UMLS CUI [2,1]
C0162563
UMLS CUI [2,2]
C0443246
UMLS CUI [2,3]
C0543467
mental impairment precluding the patient from providing informed consent or completing the appropriate follow up
Beschrijving

Mental impairment Excludes Informed Consent | Mental impairment Excludes Completion Follow-up

Datatype

boolean

Alias
UMLS CUI [1,1]
C0683322
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0683322
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0205197
UMLS CUI [2,4]
C3274571

Similar models

Eligibility Persistent Atrial Fibrillation NCT01014741

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
males and females will be enrolled in the study.
boolean
C0079399 (UMLS CUI [1])
Age
Item
age >18
boolean
C0001779 (UMLS CUI [1])
Ablation First Persistent atrial fibrillation Symptomatic | Ablation First Permanent atrial fibrillation Symptomatic | Ablation Atrial Flutter Right sided
Item
referred for a first ever ablation procedure for symptomatic persistent/permanent af (only prior ablation of right-sided typical flutter is permitted)
boolean
C0547070 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C2585653 (UMLS CUI [1,3])
C0231220 (UMLS CUI [1,4])
C0547070 (UMLS CUI [2,1])
C0205435 (UMLS CUI [2,2])
C2586056 (UMLS CUI [2,3])
C0231220 (UMLS CUI [2,4])
C0547070 (UMLS CUI [3,1])
C0004239 (UMLS CUI [3,2])
C0444532 (UMLS CUI [3,3])
Comprehension Study Protocol | Compliance behavior Follow-up
Item
all patients must understand the requirements of the study and be willing to comply with the post study follow-up requirements.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
Atrial Fibrillation
Item
patients must be in atrial fibrillation on the day of the procedure
boolean
C0004238 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cause Reversible Atrial Fibrillation | Status post Operative Surgical Procedures | Thyroid Diseases
Item
any reversible cause of af (post-surgery, thyroid disorder, etc.)
boolean
C0015127 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0040128 (UMLS CUI [3])
Myocardial Infarction | Angina, Unstable
Item
patients with a myocardial infarction or unstable angina in the previous 2 months.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
Rheumatic Heart Disease
Item
patients with a history of rheumatic heart disease
boolean
C0035439 (UMLS CUI [1])
Congenital heart disease
Item
patients with congenital heart disease
boolean
C0152021 (UMLS CUI [1])
Hypertrophic Cardiomyopathy
Item
patients with a history of hypertrophic cardiomyopathy
boolean
C0007194 (UMLS CUI [1])
Left ventricular ejection fraction
Item
patients with lv ejection fraction < 35%
boolean
C0428772 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
class iv congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Cerebral Ischemia | Transient Ischemic Attack
Item
patients who have experienced any cerebral ischemic event, including any tia in the preceding 1 month.
boolean
C0917798 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Pregnancy | Serum Beta-HCG Test Positive
Item
women who are known to be pregnant or have had a positive β-hcg test 7 days prior to procedure.
boolean
C0032961 (UMLS CUI [1])
C1255526 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Other medical condition Uncontrolled | Other medical condition Unstable | Blood Coagulation Disorders Uncontrolled
Item
patients with any other significant uncontrolled or unstable medical condition (including uncontrolled clinically significant coagulation disorders).
boolean
C3843040 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0005779 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Life Expectancy
Item
patients whose life expectancy is less than one year.
boolean
C0023671 (UMLS CUI [1])
Malignant ventricular arrhythmias | Prolonged QT interval
Item
history of malignant ventricular arrhythmias or long qt interval (>500msec)
boolean
C0857380 (UMLS CUI [1])
C0151878 (UMLS CUI [2])
Cardiac ablation Left sided Catheter | Cardiac ablation Left sided Surgical
Item
prior left-sided cardiac ablation procedure (catheter based or surgical)
boolean
C0162563 (UMLS CUI [1,1])
C0443246 (UMLS CUI [1,2])
C0085590 (UMLS CUI [1,3])
C0162563 (UMLS CUI [2,1])
C0443246 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
Mental impairment Excludes Informed Consent | Mental impairment Excludes Completion Follow-up
Item
mental impairment precluding the patient from providing informed consent or completing the appropriate follow up
boolean
C0683322 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0683322 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C3274571 (UMLS CUI [2,4])

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