ID

37638

Description

Timing of Direct Current Cardioversion (DCC) in Patients Undergoing Ablation of Persistent/Permanent Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT02429648

Lien

https://clinicaltrials.gov/show/NCT02429648

Mots-clés

Versions (1)
  1. 12/08/2019 12/08/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

12 août 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02429648

Anglais

Eligibility Atrial Fibrillation NCT02429648

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
persistent or long standing persistent af resistant to anti-arrhythmic medication. must have been present for more than 2 months
Description

Persistent atrial fibrillation Disease length | Longstanding persistent atrial fibrillation Disease length | Resistant to Anti-Arrhythmia Agents

Type de données

boolean

Alias
UMLS CUI [1,1]
C2585653
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C3873617
UMLS CUI [2,2]
C0872146
UMLS CUI [3,1]
C0332325
UMLS CUI [3,2]
C0003195
therapeutic anticoagulation for at least three weeks prior to initiation of therapy, or tee performed prior to the procedure
Description

Anticoagulation Therapy | Echocardiography, Transesophageal

Type de données

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2]
C0206054
age >= 18 years old. (females must be either post-menopausal >12 months, practicing a protocol-acceptable method of birth control
Description

Age | Postmenopausal state | Gender Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
scheduled for pulmonary vein isolation
Description

Pulmonary vein isolation Scheduled

Type de données

boolean

Alias
UMLS CUI [1,1]
C3544330
UMLS CUI [1,2]
C0205539
amiodarone will be stopped at least 3 months prior to procedure
Description

Amiodarone To be stopped

Type de données

boolean

Alias
UMLS CUI [1,1]
C0002598
UMLS CUI [1,2]
C1272691
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
reversible causes of af such as pericarditis, hyperthyroidism
Description

Cause Reversible Atrial Fibrillation | Pericarditis | Hyperthyroidism

Type de données

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0205343
UMLS CUI [1,3]
C0004238
UMLS CUI [2]
C0031046
UMLS CUI [3]
C0020550
presently with valvular heart disease requiring surgical intervention
Description

Heart valve disease Requirement Surgical intervention

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0549433
presently with coronary artery disease requiring surgical intervention
Description

Coronary Artery Disease Requirement Surgical intervention

Type de données

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0549433
early post-operative af (within three months of surgery)
Description

Atrial Fibrillation Postoperative Early

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0032790
UMLS CUI [1,3]
C1279919
previous maze or left atrial instrumentation
Description

Maze procedure for atrial fibrillation | Left atrium Instrumentation

Type de données

boolean

Alias
UMLS CUI [1]
C0397414
UMLS CUI [2,1]
C0225860
UMLS CUI [2,2]
C0587378
life expectancy <= 2 years
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
social factors that would preclude follow up or make compliance difficult.
Description

Social factor Excludes Follow-up | Social factor Difficulty with Compliance

Type de données

boolean

Alias
UMLS CUI [1,1]
C0337460
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C3274571
UMLS CUI [2,1]
C0337460
UMLS CUI [2,2]
C0332218
UMLS CUI [2,3]
C1321605
contraindication to the use of anti-arrhythmic medications and/or coumadin and heparin
Description

Medical contraindication Anti-Arrhythmia Agents | Medical contraindication Coumadin | Medical contraindication Heparin

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003195
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0699129
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0019134
enrollment in another investigational drug or device study
Description

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

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
patients with severe pulmonary disease
Description

Lung disease Severe

Type de données

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction
Description

Atrial thrombus | Neoplasm | Abnormality Excludes Catheterization

Type de données

boolean

Alias
UMLS CUI [1]
C0340517
UMLS CUI [2]
C0027651
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0007430
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Similar models

Eligibility Atrial Fibrillation NCT02429648

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Persistent atrial fibrillation Disease length | Longstanding persistent atrial fibrillation Disease length | Resistant to Anti-Arrhythmia Agents
Item
persistent or long standing persistent af resistant to anti-arrhythmic medication. must have been present for more than 2 months
boolean
C2585653 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C3873617 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C0332325 (UMLS CUI [3,1])
C0003195 (UMLS CUI [3,2])
Anticoagulation Therapy | Echocardiography, Transesophageal
Item
therapeutic anticoagulation for at least three weeks prior to initiation of therapy, or tee performed prior to the procedure
boolean
C0003281 (UMLS CUI [1])
C0206054 (UMLS CUI [2])
Age | Postmenopausal state | Gender Contraceptive methods
Item
age >= 18 years old. (females must be either post-menopausal >12 months, practicing a protocol-acceptable method of birth control
boolean
C0001779 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Pulmonary vein isolation Scheduled
Item
scheduled for pulmonary vein isolation
boolean
C3544330 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Amiodarone To be stopped
Item
amiodarone will be stopped at least 3 months prior to procedure
boolean
C0002598 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Cause Reversible Atrial Fibrillation | Pericarditis | Hyperthyroidism
Item
reversible causes of af such as pericarditis, hyperthyroidism
boolean
C0015127 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
C0031046 (UMLS CUI [2])
C0020550 (UMLS CUI [3])
Heart valve disease Requirement Surgical intervention
Item
presently with valvular heart disease requiring surgical intervention
boolean
C0018824 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0549433 (UMLS CUI [1,3])
Coronary Artery Disease Requirement Surgical intervention
Item
presently with coronary artery disease requiring surgical intervention
boolean
C1956346 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0549433 (UMLS CUI [1,3])
Atrial Fibrillation Postoperative Early
Item
early post-operative af (within three months of surgery)
boolean
C0004238 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
C1279919 (UMLS CUI [1,3])
Maze procedure for atrial fibrillation | Left atrium Instrumentation
Item
previous maze or left atrial instrumentation
boolean
C0397414 (UMLS CUI [1])
C0225860 (UMLS CUI [2,1])
C0587378 (UMLS CUI [2,2])
Life Expectancy
Item
life expectancy <= 2 years
boolean
C0023671 (UMLS CUI [1])
Social factor Excludes Follow-up | Social factor Difficulty with Compliance
Item
social factors that would preclude follow up or make compliance difficult.
boolean
C0337460 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
C0337460 (UMLS CUI [2,1])
C0332218 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
Medical contraindication Anti-Arrhythmia Agents | Medical contraindication Coumadin | Medical contraindication Heparin
Item
contraindication to the use of anti-arrhythmic medications and/or coumadin and heparin
boolean
C1301624 (UMLS CUI [1,1])
C0003195 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0699129 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0019134 (UMLS CUI [3,2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
enrollment in another investigational drug or device study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Lung disease Severe
Item
patients with severe pulmonary disease
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Atrial thrombus | Neoplasm | Abnormality Excludes Catheterization
Item
documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction
boolean
C0340517 (UMLS CUI [1])
C0027651 (UMLS CUI [2])
C1704258 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0007430 (UMLS CUI [3,3])
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