ID

37528

Description

Hybrid AF -- A Prospective Registry; ODM derived from: https://clinicaltrials.gov/show/NCT01636518

Lien

https://clinicaltrials.gov/show/NCT01636518

Mots-clés

Versions (1)
  1. 05/08/2019 05/08/2019 -
Détendeur de droits

See clinicaltrials.gov

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5 août 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01636518

Anglais

Eligibility Atrial Fibrillation NCT01636518

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented effectiveness failure of at least one vaughan-williams class iii aad
Description

Anti-Arrhythmia Agents Classification | Anti-Arrhythmia Agents Quantity failed

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C0008902
UMLS CUI [2,1]
C0003195
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
persistent af as defined by the hrs/ehra/ecas expert consensus statement on catheter and surgical ablation of atrial fibrillation
Description

Persistent atrial fibrillation

Type de données

boolean

Alias
UMLS CUI [1]
C2585653
absence of significant structural heart disease as demonstrated by a transthoracic echocardiogram (tte) of all four chambers of the heart, computed tomography (ct) scan or magnetic resonance imaging (mri) scan within 6 months prior to enrollment
Description

Structural disorder of heart Absent | Cardiac chamber All TTE | Structural disorder of heart Absent CT scan | Structural disorder of heart Absent MRI scan

Type de données

boolean

Alias
UMLS CUI [1,1]
C1290384
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0729936
UMLS CUI [2,2]
C0444868
UMLS CUI [2,3]
C0430462
UMLS CUI [3,1]
C1290384
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0040405
UMLS CUI [4,1]
C1290384
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0024485
absence of left atrial thrombus as documented by an imaging study (e.g., tte, transesophageal echocardiogram (tee), thoracic ct scan, mri, or left atrial angiography) within 30 days prior to procedure
Description

Thrombus of left atrium Absent imaging study | Thrombus of left atrium Absent TTE | Thrombus of left atrium Absent TEE | Thrombus of left atrium Absent CT scan Thorax | Thrombus of left atrium Absent MRI | Thrombus of left atrium Absent Left atrium Angiography

Type de données

boolean

Alias
UMLS CUI [1,1]
C3532827
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1881134
UMLS CUI [2,1]
C3532827
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0430462
UMLS CUI [3,1]
C3532827
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0206054
UMLS CUI [4,1]
C3532827
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0202823
UMLS CUI [5,1]
C3532827
UMLS CUI [5,2]
C0332197
UMLS CUI [5,3]
C0024485
UMLS CUI [6,1]
C3532827
UMLS CUI [6,2]
C0332197
UMLS CUI [6,3]
C0225860
UMLS CUI [6,4]
C0002978
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of longstanding persistent af for more than 3 years
Description

Longstanding persistent atrial fibrillation Disease length

Type de données

boolean

Alias
UMLS CUI [1,1]
C3873617
UMLS CUI [1,2]
C0872146
documented left atrial size of 60 mm or more
Description

Left atrium Size

Type de données

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0456389
documented left ventricular ejection fraction (lvef) less than 40%
Description

Left ventricular ejection fraction

Type de données

boolean

Alias
UMLS CUI [1]
C0428772
history of cerebrovascular disease, including stroke or transient ischemic attack (tia) within 6 months prior to enrollment
Description

Cerebrovascular Disorder | Cerebrovascular accident | Transient Ischemic Attack

Type de données

boolean

Alias
UMLS CUI [1]
C0007820
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
significant underlying structural heart disease requiring surgical or procedural intervention within the last six months of initial procedure
Description

Structural disorder of heart Requirement Operative Surgical Procedures | Structural disorder of heart Requirement Interventional procedure

Type de données

boolean

Alias
UMLS CUI [1,1]
C1290384
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C1290384
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0184661
known contraindication to anticoagulant therapy, or inability to comply with anticoagulant therapy
Description

Medical contraindication Anticoagulant therapy | Compliance Anticoagulant therapy Unable

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0150457
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0150457
UMLS CUI [2,3]
C1299582
other clinical conditions precluding inclusion (e.g., organ disease, disturbances of hemostasis, etc.)
Description

Medical condition Study Subject Participation Status Excluded | Organ Disease | Hemostasis Disturbance

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0178784
UMLS CUI [2,2]
C0012634
UMLS CUI [3,1]
C0019116
UMLS CUI [3,2]
C2699787
pregnancy, planned pregnancy (females of childbearing potential must have a negative pregnancy test prior to enrollment and agree not to become pregnant during the trial) or breastfeeding;
Description

Pregnancy | Pregnancy, Planned | Breast Feeding | Childbearing Potential Pregnancy test negative

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0427780
concomitant procedure planned
Description

Procedure Concomitant Planned

Type de données

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0521115
UMLS CUI [1,3]
C1301732
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Similar models

Eligibility Atrial Fibrillation NCT01636518

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Anti-Arrhythmia Agents Classification | Anti-Arrhythmia Agents Quantity failed
Item
documented effectiveness failure of at least one vaughan-williams class iii aad
boolean
C0003195 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
C0003195 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Persistent atrial fibrillation
Item
persistent af as defined by the hrs/ehra/ecas expert consensus statement on catheter and surgical ablation of atrial fibrillation
boolean
C2585653 (UMLS CUI [1])
Structural disorder of heart Absent | Cardiac chamber All TTE | Structural disorder of heart Absent CT scan | Structural disorder of heart Absent MRI scan
Item
absence of significant structural heart disease as demonstrated by a transthoracic echocardiogram (tte) of all four chambers of the heart, computed tomography (ct) scan or magnetic resonance imaging (mri) scan within 6 months prior to enrollment
boolean
C1290384 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0729936 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
C0430462 (UMLS CUI [2,3])
C1290384 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C1290384 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
Thrombus of left atrium Absent imaging study | Thrombus of left atrium Absent TTE | Thrombus of left atrium Absent TEE | Thrombus of left atrium Absent CT scan Thorax | Thrombus of left atrium Absent MRI | Thrombus of left atrium Absent Left atrium Angiography
Item
absence of left atrial thrombus as documented by an imaging study (e.g., tte, transesophageal echocardiogram (tee), thoracic ct scan, mri, or left atrial angiography) within 30 days prior to procedure
boolean
C3532827 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1881134 (UMLS CUI [1,3])
C3532827 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0430462 (UMLS CUI [2,3])
C3532827 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0206054 (UMLS CUI [3,3])
C3532827 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0202823 (UMLS CUI [4,3])
C3532827 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0024485 (UMLS CUI [5,3])
C3532827 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0225860 (UMLS CUI [6,3])
C0002978 (UMLS CUI [6,4])
Item Group
C0680251 (UMLS CUI)
Longstanding persistent atrial fibrillation Disease length
Item
history of longstanding persistent af for more than 3 years
boolean
C3873617 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Left atrium Size
Item
documented left atrial size of 60 mm or more
boolean
C0225860 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
documented left ventricular ejection fraction (lvef) less than 40%
boolean
C0428772 (UMLS CUI [1])
Cerebrovascular Disorder | Cerebrovascular accident | Transient Ischemic Attack
Item
history of cerebrovascular disease, including stroke or transient ischemic attack (tia) within 6 months prior to enrollment
boolean
C0007820 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Structural disorder of heart Requirement Operative Surgical Procedures | Structural disorder of heart Requirement Interventional procedure
Item
significant underlying structural heart disease requiring surgical or procedural intervention within the last six months of initial procedure
boolean
C1290384 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C1290384 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
Medical contraindication Anticoagulant therapy | Compliance Anticoagulant therapy Unable
Item
known contraindication to anticoagulant therapy, or inability to comply with anticoagulant therapy
boolean
C1301624 (UMLS CUI [1,1])
C0150457 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0150457 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Medical condition Study Subject Participation Status Excluded | Organ Disease | Hemostasis Disturbance
Item
other clinical conditions precluding inclusion (e.g., organ disease, disturbances of hemostasis, etc.)
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0178784 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0019116 (UMLS CUI [3,1])
C2699787 (UMLS CUI [3,2])
Pregnancy | Pregnancy, Planned | Breast Feeding | Childbearing Potential Pregnancy test negative
Item
pregnancy, planned pregnancy (females of childbearing potential must have a negative pregnancy test prior to enrollment and agree not to become pregnant during the trial) or breastfeeding;
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0427780 (UMLS CUI [4,2])
Procedure Concomitant Planned
Item
concomitant procedure planned
boolean
C0184661 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
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