ID

37574

Description

Cardiac Resynchronization in Atrial Fibrillation Trial - a Pilot Study; ODM derived from: https://clinicaltrials.gov/show/NCT01850277

Link

https://clinicaltrials.gov/show/NCT01850277

Keywords

Versions (1)
  1. 8/8/19 8/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 8, 2019

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01850277

English

Eligibility Atrial Fibrillation NCT01850277

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
permanent or long-standing persistent atrial fibrillation (definitions according to the latest european society of cardiology guidelines on af)
Description

Permanent atrial fibrillation | Longstanding persistent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2586056
UMLS CUI [2]
C3873617
at least 3 months after a procedure of a crt device implantation
Description

Implantation Cardiac Resynchronization Therapy Device

Data type

boolean

Alias
UMLS CUI [1,1]
C0021107
UMLS CUI [1,2]
C2936377
a crt device with a presence of a right atrial electrode
Description

Cardiac Resynchronization Therapy Device | Right atrium electrode Present

Data type

boolean

Alias
UMLS CUI [1]
C2936377
UMLS CUI [2,1]
C0225844
UMLS CUI [2,2]
C0013812
UMLS CUI [2,3]
C0150312
age: ≥18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
effectively biventricular paced captured beats <95%
Description

Heart beat Paced biventricular

Data type

boolean

Alias
UMLS CUI [1,1]
C0425583
UMLS CUI [1,2]
C2981711
UMLS CUI [1,3]
C0699808
effective therapy with oral anticoagulants for at least 3 months
Description

Oral anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C0354604
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
reversible causes of af
Description

Causes Reversible Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0205343
UMLS CUI [1,3]
C0004238
significant valve disease
Description

Valvular disease

Data type

boolean

Alias
UMLS CUI [1]
C3258293
advanced a-v block (including: avja)
Description

Atrioventricular Block Advanced | Catheter ablation Atrioventricular junction

Data type

boolean

Alias
UMLS CUI [1,1]
C0004245
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0162563
UMLS CUI [2,2]
C0729580
contraindications to amiodarone (hyperthyroidism, not compensated hypothyroidism, drug intolerance, qt>460ms for men, qt>450 for women)
Description

Medical contraindication Amiodarone | Hyperthyroidism | Hypothyroidism Uncompensated | Drug intolerance | Prolonged QT interval | Gender

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0002598
UMLS CUI [2]
C0020550
UMLS CUI [3,1]
C0020676
UMLS CUI [3,2]
C0205433
UMLS CUI [4]
C0277585
UMLS CUI [5]
C0151878
UMLS CUI [6]
C0079399
long-qt syndrome
Description

Long QT Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0023976
decompensation of the heart failure within 48 hours before the qualification
Description

Decompensation Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0231187
UMLS CUI [1,2]
C0018801
cardiac transplantation in 6 months
Description

Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0018823
life expectancy less than 1 year
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
chronic dialysis
Description

Chronic dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0743165
la diameter >6cm
Description

Left atrium Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C1301886
alcohol abuse
Description

Alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0085762
pregnancy/lack of effective contraceptive therapy (in case of females in the reproductive age)
Description

Pregnancy | Childbearing Potential Contraceptive methods Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332268
participation in other clinical trial
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Atrial Fibrillation NCT01850277

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Permanent atrial fibrillation | Longstanding persistent atrial fibrillation
Item
permanent or long-standing persistent atrial fibrillation (definitions according to the latest european society of cardiology guidelines on af)
boolean
C2586056 (UMLS CUI [1])
C3873617 (UMLS CUI [2])
Implantation Cardiac Resynchronization Therapy Device
Item
at least 3 months after a procedure of a crt device implantation
boolean
C0021107 (UMLS CUI [1,1])
C2936377 (UMLS CUI [1,2])
Cardiac Resynchronization Therapy Device | Right atrium electrode Present
Item
a crt device with a presence of a right atrial electrode
boolean
C2936377 (UMLS CUI [1])
C0225844 (UMLS CUI [2,1])
C0013812 (UMLS CUI [2,2])
C0150312 (UMLS CUI [2,3])
Age
Item
age: ≥18 years old
boolean
C0001779 (UMLS CUI [1])
Heart beat Paced biventricular
Item
effectively biventricular paced captured beats <95%
boolean
C0425583 (UMLS CUI [1,1])
C2981711 (UMLS CUI [1,2])
C0699808 (UMLS CUI [1,3])
Oral anticoagulants
Item
effective therapy with oral anticoagulants for at least 3 months
boolean
C0354604 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Causes Reversible Atrial Fibrillation
Item
reversible causes of af
boolean
C0015127 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
Valvular disease
Item
significant valve disease
boolean
C3258293 (UMLS CUI [1])
Atrioventricular Block Advanced | Catheter ablation Atrioventricular junction
Item
advanced a-v block (including: avja)
boolean
C0004245 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0162563 (UMLS CUI [2,1])
C0729580 (UMLS CUI [2,2])
Medical contraindication Amiodarone | Hyperthyroidism | Hypothyroidism Uncompensated | Drug intolerance | Prolonged QT interval | Gender
Item
contraindications to amiodarone (hyperthyroidism, not compensated hypothyroidism, drug intolerance, qt>460ms for men, qt>450 for women)
boolean
C1301624 (UMLS CUI [1,1])
C0002598 (UMLS CUI [1,2])
C0020550 (UMLS CUI [2])
C0020676 (UMLS CUI [3,1])
C0205433 (UMLS CUI [3,2])
C0277585 (UMLS CUI [4])
C0151878 (UMLS CUI [5])
C0079399 (UMLS CUI [6])
Long QT Syndrome
Item
long-qt syndrome
boolean
C0023976 (UMLS CUI [1])
Decompensation Heart failure
Item
decompensation of the heart failure within 48 hours before the qualification
boolean
C0231187 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
Heart Transplantation
Item
cardiac transplantation in 6 months
boolean
C0018823 (UMLS CUI [1])
Life Expectancy
Item
life expectancy less than 1 year
boolean
C0023671 (UMLS CUI [1])
Chronic dialysis
Item
chronic dialysis
boolean
C0743165 (UMLS CUI [1])
Left atrium Diameter
Item
la diameter >6cm
boolean
C0225860 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Alcohol abuse
Item
alcohol abuse
boolean
C0085762 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods Lacking
Item
pregnancy/lack of effective contraceptive therapy (in case of females in the reproductive age)
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Study Subject Participation Status
Item
participation in other clinical trial
boolean
C2348568 (UMLS CUI [1])
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