ID

31483

Descrição

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

Link

https://clinicaltrials.gov/show/NCT01014741

Palavras-chave

Versões (1)
  1. 27/08/2018 27/08/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

27 de agosto de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Persistent Atrial Fibrillation NCT01014741

Inglês

Eligibility Persistent Atrial Fibrillation NCT01014741

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
age >18
Descrição

Age

Tipo de dados

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)
Descrição

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

Tipo de dados

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.
Descrição

Comprehension Study Protocol | Compliance behavior Follow-up

Tipo de dados

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
Descrição

Atrial Fibrillation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004238
Exclusion Criteria
Descrição

Exclusion Criteria

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

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

Tipo de dados

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.
Descrição

Myocardial Infarction | Angina, Unstable

Tipo de dados

boolean

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

Rheumatic Heart Disease

Tipo de dados

boolean

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

Congenital heart disease

Tipo de dados

boolean

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

Hypertrophic Cardiomyopathy

Tipo de dados

boolean

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

Left ventricular ejection fraction

Tipo de dados

boolean

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

Congestive heart failure New York Heart Association Classification

Tipo de dados

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.
Descrição

Cerebral Ischemia | Transient Ischemic Attack

Tipo de dados

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.
Descrição

Pregnancy | Serum Beta-HCG Test Positive

Tipo de dados

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).
Descrição

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

Tipo de dados

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.
Descrição

Life Expectancy

Tipo de dados

boolean

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

Malignant ventricular arrhythmias | Prolonged QT interval

Tipo de dados

boolean

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

Cardiac ablation Left sided Catheter | Cardiac ablation Left sided Surgical

Tipo de dados

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
Descrição

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

Tipo de dados

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
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Similar models

Eligibility Persistent Atrial Fibrillation NCT01014741

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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