ID

39264

Beskrivning

Deviating the Esophagus in Atrial Fibrillation Ablation; ODM derived from: https://clinicaltrials.gov/show/NCT01546168

Länk

https://clinicaltrials.gov/show/NCT01546168

Nyckelord

Versioner (1)
  1. 2019-12-14 2019-12-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 december 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Esophageal Deviation NCT01546168

Engelsk

Eligibility Esophageal Deviation NCT01546168

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >18 - age < 80 yr
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
documentation of atrial fibrillation (af)
Beskrivning

Atrial Fibrillation

Datatyp

boolean

Alias
UMLS CUI [1]
C0004238
referred for a first ever ablation procedure for af (prior ablation of right-sided typical flutter, or "limited" left-sided of an accessory pathway are permitted)
Beskrivning

Referral for Catheter ablation for atrial fibrillation | Ablation Atrial Flutter Right sided

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2585524
UMLS CUI [1,2]
C2702800
UMLS CUI [2,1]
C0547070
UMLS CUI [2,2]
C0004239
UMLS CUI [2,3]
C0444532
general anesthesia
Beskrivning

General Anesthesia

Datatyp

boolean

Alias
UMLS CUI [1]
C0002915
all patients must understand and adhere to the requirements of the study and be willing to comply with the post study follow-up requirements.
Beskrivning

Protocol Compliance | Compliance Follow-up

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C3274571
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Cause Reversible Atrial Fibrillation | Status post Operative Surgical Procedure | Thyroid Disease

Datatyp

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
inr > 4.0 at the time of the procedure
Beskrivning

International Normalized Ratio

Datatyp

boolean

Alias
UMLS CUI [1]
C0525032
h/o of severe esophageal ulcers, strictures, esophagitis or gerd
Beskrivning

Ulcer of esophagus Severe | Stricture Esophagus | Esophagitis | Gastroesophageal reflux disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0151970
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1261287
UMLS CUI [2,2]
C0014876
UMLS CUI [3]
C0014868
UMLS CUI [4]
C0017168
h/o esophageal surgery
Beskrivning

Operation on esophagus

Datatyp

boolean

Alias
UMLS CUI [1]
C0192259
prior surgical or catheter ablation procedure for af (except right atrial flutter ablation)
Beskrivning

Ablation Atrial Fibrillation | Catheter ablation for atrial fibrillation | Exception Ablation Atrial Flutter Right sided

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0547070
UMLS CUI [1,2]
C0004238
UMLS CUI [2]
C2702800
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0547070
UMLS CUI [3,3]
C0004239
UMLS CUI [3,4]
C0444532
any evidence of esophageal diverticulum or other structural abnormalities of the esophagus seen during baseline barium esophagogram
Beskrivning

Esophageal diverticulum | MISCELLANEOUS STRUCTURAL ABNORMALITIES Esophagus

Datatyp

boolean

Alias
UMLS CUI [1]
C0014854
UMLS CUI [2,1]
C0333310
UMLS CUI [2,2]
C0014876
significant abnormality on swallowing impairment score
Beskrivning

Abnormality Swallowing Impairment Scale

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C4526769
mental impairment precluding signing consent or completing follow up
Beskrivning

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

Datatyp

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]
C3274571
patients with any other significant uncontrolled or unstable medical condition
Beskrivning

Other medical condition Uncontrolled | Other medical condition Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
women who are known to be pregnant or have had a positive β-hcg test 7 days prior to procedure
Beskrivning

Pregnancy | HCG pregnancy test Positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0546577
UMLS CUI [2,2]
C1514241
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Similar models

Eligibility Esophageal Deviation NCT01546168

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age >18 - age < 80 yr
boolean
C0001779 (UMLS CUI [1])
Atrial Fibrillation
Item
documentation of atrial fibrillation (af)
boolean
C0004238 (UMLS CUI [1])
Referral for Catheter ablation for atrial fibrillation | Ablation Atrial Flutter Right sided
Item
referred for a first ever ablation procedure for af (prior ablation of right-sided typical flutter, or "limited" left-sided of an accessory pathway are permitted)
boolean
C2585524 (UMLS CUI [1,1])
C2702800 (UMLS CUI [1,2])
C0547070 (UMLS CUI [2,1])
C0004239 (UMLS CUI [2,2])
C0444532 (UMLS CUI [2,3])
General Anesthesia
Item
general anesthesia
boolean
C0002915 (UMLS CUI [1])
Protocol Compliance | Compliance Follow-up
Item
all patients must understand and adhere to the requirements of the study and be willing to comply with the post study follow-up requirements.
boolean
C0525058 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Cause Reversible Atrial Fibrillation | Status post Operative Surgical Procedure | Thyroid Disease
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])
International Normalized Ratio
Item
inr > 4.0 at the time of the procedure
boolean
C0525032 (UMLS CUI [1])
Ulcer of esophagus Severe | Stricture Esophagus | Esophagitis | Gastroesophageal reflux disease
Item
h/o of severe esophageal ulcers, strictures, esophagitis or gerd
boolean
C0151970 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1261287 (UMLS CUI [2,1])
C0014876 (UMLS CUI [2,2])
C0014868 (UMLS CUI [3])
C0017168 (UMLS CUI [4])
Operation on esophagus
Item
h/o esophageal surgery
boolean
C0192259 (UMLS CUI [1])
Ablation Atrial Fibrillation | Catheter ablation for atrial fibrillation | Exception Ablation Atrial Flutter Right sided
Item
prior surgical or catheter ablation procedure for af (except right atrial flutter ablation)
boolean
C0547070 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C2702800 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0547070 (UMLS CUI [3,2])
C0004239 (UMLS CUI [3,3])
C0444532 (UMLS CUI [3,4])
Esophageal diverticulum | MISCELLANEOUS STRUCTURAL ABNORMALITIES Esophagus
Item
any evidence of esophageal diverticulum or other structural abnormalities of the esophagus seen during baseline barium esophagogram
boolean
C0014854 (UMLS CUI [1])
C0333310 (UMLS CUI [2,1])
C0014876 (UMLS CUI [2,2])
Abnormality Swallowing Impairment Scale
Item
significant abnormality on swallowing impairment score
boolean
C1704258 (UMLS CUI [1,1])
C4526769 (UMLS CUI [1,2])
Mental impairment Excludes Informed Consent | Mental impairment Excludes Follow-up
Item
mental impairment precluding signing consent or completing 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])
C3274571 (UMLS CUI [2,3])
Other medical condition Uncontrolled | Other medical condition Unstable
Item
patients with any other significant uncontrolled or unstable medical condition
boolean
C3843040 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Pregnancy | HCG pregnancy 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])
C0546577 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
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