ID

23472

Descripción

Surgical or Catheter Ablation of Lone Atrial Fibrillation (AF) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00703157

Link

https://clinicaltrials.gov/show/NCT00703157

Palabras clave

Versiones (1)
  1. 6/7/17 6/7/17 -
Subido en

6 de julio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00703157

Inglés

Eligibility Atrial Fibrillation NCT00703157

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient has documented paroxysmal af as defined by the acc/aha/esc guidelines
Descripción

Paroxysmal atrial fibrillation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0235480
minimal one documented af episode in the last 6 months
Descripción

Atrial Fibrillation Episode Quantity Minimum

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C1524031
refractory to minimal two class i or iii anti-arrhythmic drug
Descripción

Anti-Arrhythmia Agents refractory | Anti-Arrhythmia Agents Class Quantity Minimum

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0003195
UMLS CUI [2,2]
C0456387
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C1524031
age > 18 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
signed and dated the patient informed consent.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
patient can tolerate anti-coagulation therapy (warfarin/coumadin)
Descripción

Anticoagulation Therapy Receive Ability | Warfarin | Coumadin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0085732
UMLS CUI [2]
C0043031
UMLS CUI [3]
C0699129
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has a structural heart disease
Descripción

Structural disorder of heart

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1290384
ejection fraction < 40 %
Descripción

Cardiac ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232174
echocardiographic evidence for a left atrium > 45 mm (parasternal axis)
Descripción

Left atrium Size | Echocardiography Axis Parasternal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0013516
UMLS CUI [2,2]
C1522496
UMLS CUI [2,3]
C0442146
patients on amiodarone, or patients known to be intolerant for amiodarone
Descripción

Amiodarone | Intolerance to Amiodarone

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002598
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0002598
dextrocardia, current endocarditis, systemic infection, renal failure
Descripción

Dextrocardia | Endocarditis | Sepsis | Kidney Failure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011813
UMLS CUI [2]
C0014118
UMLS CUI [3]
C0243026
UMLS CUI [4]
C0035078
patient has known cerebrovascular disease, including a history of stroke, cva or tia
Descripción

Cerebrovascular Disorders | Cerebrovascular accident | Transient Ischemic Attack

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007820
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
pregnancy at enrolment; or planned pregnancy within the follow up period
Descripción

Pregnancy | Pregnancy, Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
patient has a life expectancy less than 1 year
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
the subject is participating in another device or drug study
Descripción

Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2346570
UMLS CUI [3]
C0013230
the patient is unable and/or unwilling to cooperate with study procedures or required follow up visits
Descripción

Protocol Compliance Unable | Protocol Compliance Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
echocardiographic (tte) evidence for presence of left atrial thrombus
Descripción

Thrombus of left atrium Transthoracic echocardiography

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3532827
UMLS CUI [1,2]
C0430462
previous (cardio-) thoracic surgery
Descripción

Thoracic Surgical Procedures | Cardiothoracic surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0524832
UMLS CUI [2]
C2242990
previous left atrial ablation
Descripción

Left atrium Ablation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0547070
patients with permanent or persistent af
Descripción

Permanent atrial fibrillation | Persistent atrial fibrillation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2586056
UMLS CUI [2]
C2585653
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Similar models

Eligibility Atrial Fibrillation NCT00703157

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Paroxysmal atrial fibrillation
Item
patient has documented paroxysmal af as defined by the acc/aha/esc guidelines
boolean
C0235480 (UMLS CUI [1])
Atrial Fibrillation Episode Quantity Minimum
Item
minimal one documented af episode in the last 6 months
boolean
C0004238 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1524031 (UMLS CUI [1,4])
Anti-Arrhythmia Agents refractory | Anti-Arrhythmia Agents Class Quantity Minimum
Item
refractory to minimal two class i or iii anti-arrhythmic drug
boolean
C0003195 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0003195 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1524031 (UMLS CUI [2,4])
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
signed and dated the patient informed consent.
boolean
C0021430 (UMLS CUI [1])
Anticoagulation Therapy Receive Ability | Warfarin | Coumadin
Item
patient can tolerate anti-coagulation therapy (warfarin/coumadin)
boolean
C0003281 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0043031 (UMLS CUI [2])
C0699129 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Structural disorder of heart
Item
patient has a structural heart disease
boolean
C1290384 (UMLS CUI [1])
Cardiac ejection fraction
Item
ejection fraction < 40 %
boolean
C0232174 (UMLS CUI [1])
Left atrium Size | Echocardiography Axis Parasternal
Item
echocardiographic evidence for a left atrium > 45 mm (parasternal axis)
boolean
C0225860 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0013516 (UMLS CUI [2,1])
C1522496 (UMLS CUI [2,2])
C0442146 (UMLS CUI [2,3])
Amiodarone | Intolerance to Amiodarone
Item
patients on amiodarone, or patients known to be intolerant for amiodarone
boolean
C0002598 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0002598 (UMLS CUI [2,2])
Dextrocardia | Endocarditis | Sepsis | Kidney Failure
Item
dextrocardia, current endocarditis, systemic infection, renal failure
boolean
C0011813 (UMLS CUI [1])
C0014118 (UMLS CUI [2])
C0243026 (UMLS CUI [3])
C0035078 (UMLS CUI [4])
Cerebrovascular Disorders | Cerebrovascular accident | Transient Ischemic Attack
Item
patient has known cerebrovascular disease, including a history of stroke, cva or tia
boolean
C0007820 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Pregnancy | Pregnancy, Planned
Item
pregnancy at enrolment; or planned pregnancy within the follow up period
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Life Expectancy
Item
patient has a life expectancy less than 1 year
boolean
C0023671 (UMLS CUI [1])
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs
Item
the subject is participating in another device or drug study
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
the patient is unable and/or unwilling to cooperate with study procedures or required follow up visits
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Thrombus of left atrium Transthoracic echocardiography
Item
echocardiographic (tte) evidence for presence of left atrial thrombus
boolean
C3532827 (UMLS CUI [1,1])
C0430462 (UMLS CUI [1,2])
Thoracic Surgical Procedures | Cardiothoracic surgery
Item
previous (cardio-) thoracic surgery
boolean
C0524832 (UMLS CUI [1])
C2242990 (UMLS CUI [2])
Left atrium Ablation
Item
previous left atrial ablation
boolean
C0225860 (UMLS CUI [1,1])
C0547070 (UMLS CUI [1,2])
Permanent atrial fibrillation | Persistent atrial fibrillation
Item
patients with permanent or persistent af
boolean
C2586056 (UMLS CUI [1])
C2585653 (UMLS CUI [2])
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