ID

37489

Descripción

Substrate Ablation and Remodelling in Non-paroxysmal Atrial Fibrillation (AF); ODM derived from: https://clinicaltrials.gov/show/NCT01445925

Link

https://clinicaltrials.gov/show/NCT01445925

Palabras clave

Versiones (1)
  1. 2/8/19 2/8/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

2 de agosto de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01445925

Inglés

Eligibility Atrial Fibrillation NCT01445925

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
ongoing symptoms (european heart rhythm association class 2 or above) in spite of treatment with rate control medication
Descripción

Symptoms Heart rate rhythm Class | Pharmacotherapy Heart rate Control

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0489522
UMLS CUI [1,3]
C0456387
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0018810
UMLS CUI [2,3]
C2587213
non-paroxysmal atrial fibrillation, as pre-classified as
Descripción

Atrial Fibrillation | Exception Paroxysmal atrial fibrillation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0235480
persistent af: af requiring electrical/ chemical cardioversion or that lasting >7 days. these patients may be in af or in sinus rhythm at the time of their initial assessment and/ or at the time of their ablation.
Descripción

Persistent atrial fibrillation Requirement Electric Countershock | Persistent atrial fibrillation Requirement Chemical cardioversion | Persistent atrial fibrillation Disease length | Atrial Fibrillation | Sinus rhythm

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2585653
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013778
UMLS CUI [2,1]
C2585653
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C2585199
UMLS CUI [3,1]
C2585653
UMLS CUI [3,2]
C0872146
UMLS CUI [4]
C0004238
UMLS CUI [5]
C0232201
continuous persistent af: these patients are persistently in af with or without antiarrhythmic drug therapy, as confirmed on a 24 hour holter. they may have undergone previous cardioversion(s).
Descripción

Persistent atrial fibrillation Continuous Holter Electrocardiography | Anti-Arrhythmia Agents | Anti-Arrhythmia Agents Absent | Electric Countershock Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2585653
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0013801
UMLS CUI [2]
C0003195
UMLS CUI [3,1]
C0003195
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0013778
UMLS CUI [4,2]
C0205156
sustained paroxysmal af with underlying substrate: patients with individual af episode(s) lasting >12 hours but less than 7 days plus one or more of the following:
Descripción

Paroxysmal atrial fibrillation | Atrial Fibrillation Episode Duration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C0449238
age >65 years 21
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
individual af episode(s) lasting >24 hours
Descripción

Atrial Fibrillation Episode Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0449238
significant left atrial dilatation of >45 mm on echo (parasternal long axis view)
Descripción

Left atrial dilatation Echocardiography Parasternal long axis view

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0344720
UMLS CUI [1,2]
C0013516
UMLS CUI [1,3]
C1302222
obesity (body mass index >30), and/ or history suggestive of sleep apnoea
Descripción

Obesity | Body mass index | Suggestive of Sleep Apnea

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0028754
UMLS CUI [2]
C1305855
UMLS CUI [3,1]
C0332299
UMLS CUI [3,2]
C0037315
diabetes mellitus requiring hypoglycaemic drugs and/or insulin
Descripción

Diabetes Mellitus Requirement Hypoglycemic Agents | Diabetes Mellitus Requirement Insulin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0020616
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0021641
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability or unwillingness to receive oral anticoagulation with warfarin
Descripción

Oral anticoagulant Warfarin Receive Unable | Oral anticoagulant Warfarin Receive Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0354604
UMLS CUI [1,2]
C0043031
UMLS CUI [1,3]
C1514756
UMLS CUI [1,4]
C1299582
UMLS CUI [2,1]
C0354604
UMLS CUI [2,2]
C0043031
UMLS CUI [2,3]
C1514756
UMLS CUI [2,4]
C0558080
previous ablation procedure for af
Descripción

Catheter ablation for atrial fibrillation Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C0205156
unwillingness or inability to complete the required follow up arrangements
Descripción

Follow-up Completion Unwilling | Follow-up Completion Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C1299582
presence of long standing persistent af with continuous af longer than 12 months. this includes patients in whom sinus rhythm may have been maintained following electrical cardioversion for a period of less than 1 week at a stretch.
Descripción

Longstanding persistent atrial fibrillation Duration | Sinus rhythm Following Electric Countershock

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3873617
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0232201
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C0013778
documented typical atrial flutter
Descripción

Typical atrial flutter

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3264370
prior prosthetic mitral valve replacement or severe structural cardiac abnormality
Descripción

Replacement of mitral valve | Structural Heart Abnormality Severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0026268
UMLS CUI [2,1]
C3274789
UMLS CUI [2,2]
C0205082
contraindications and/ or prior intolerance to both amiodarone and flecainide.
Descripción

Medical contraindication Amiodarone | Intolerance to Amiodarone | Medical contraindication Flecainide | Intolerance to Flecainide

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0002598
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0002598
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0016229
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0016229
reversible cause for atrial fibrillation
Descripción

Cause Reversible Atrial Fibrillation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0205343
UMLS CUI [1,3]
C0004238
known hypertrophic or infiltrative cardiomyopathy
Descripción

Hypertrophic Cardiomyopathy | Cardiomyopathy Infiltrating

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2,1]
C0878544
UMLS CUI [2,2]
C0332448
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Similar models

Eligibility Atrial Fibrillation NCT01445925

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Symptoms Heart rate rhythm Class | Pharmacotherapy Heart rate Control
Item
ongoing symptoms (european heart rhythm association class 2 or above) in spite of treatment with rate control medication
boolean
C1457887 (UMLS CUI [1,1])
C0489522 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
C0013216 (UMLS CUI [2,1])
C0018810 (UMLS CUI [2,2])
C2587213 (UMLS CUI [2,3])
Atrial Fibrillation | Exception Paroxysmal atrial fibrillation
Item
non-paroxysmal atrial fibrillation, as pre-classified as
boolean
C0004238 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0235480 (UMLS CUI [2,2])
Persistent atrial fibrillation Requirement Electric Countershock | Persistent atrial fibrillation Requirement Chemical cardioversion | Persistent atrial fibrillation Disease length | Atrial Fibrillation | Sinus rhythm
Item
persistent af: af requiring electrical/ chemical cardioversion or that lasting >7 days. these patients may be in af or in sinus rhythm at the time of their initial assessment and/ or at the time of their ablation.
boolean
C2585653 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013778 (UMLS CUI [1,3])
C2585653 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C2585199 (UMLS CUI [2,3])
C2585653 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
C0004238 (UMLS CUI [4])
C0232201 (UMLS CUI [5])
Persistent atrial fibrillation Continuous Holter Electrocardiography | Anti-Arrhythmia Agents | Anti-Arrhythmia Agents Absent | Electric Countershock Previous
Item
continuous persistent af: these patients are persistently in af with or without antiarrhythmic drug therapy, as confirmed on a 24 hour holter. they may have undergone previous cardioversion(s).
boolean
C2585653 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0013801 (UMLS CUI [1,3])
C0003195 (UMLS CUI [2])
C0003195 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0013778 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
Paroxysmal atrial fibrillation | Atrial Fibrillation Episode Duration
Item
sustained paroxysmal af with underlying substrate: patients with individual af episode(s) lasting >12 hours but less than 7 days plus one or more of the following:
boolean
C0235480 (UMLS CUI [1])
C0004238 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Age
Item
age >65 years 21
boolean
C0001779 (UMLS CUI [1])
Atrial Fibrillation Episode Duration
Item
individual af episode(s) lasting >24 hours
boolean
C0004238 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Left atrial dilatation Echocardiography Parasternal long axis view
Item
significant left atrial dilatation of >45 mm on echo (parasternal long axis view)
boolean
C0344720 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C1302222 (UMLS CUI [1,3])
Obesity | Body mass index | Suggestive of Sleep Apnea
Item
obesity (body mass index >30), and/ or history suggestive of sleep apnoea
boolean
C0028754 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
C0332299 (UMLS CUI [3,1])
C0037315 (UMLS CUI [3,2])
Diabetes Mellitus Requirement Hypoglycemic Agents | Diabetes Mellitus Requirement Insulin
Item
diabetes mellitus requiring hypoglycaemic drugs and/or insulin
boolean
C0011849 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0020616 (UMLS CUI [1,3])
C0011849 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021641 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Oral anticoagulant Warfarin Receive Unable | Oral anticoagulant Warfarin Receive Unwilling
Item
inability or unwillingness to receive oral anticoagulation with warfarin
boolean
C0354604 (UMLS CUI [1,1])
C0043031 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0354604 (UMLS CUI [2,1])
C0043031 (UMLS CUI [2,2])
C1514756 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
Catheter ablation for atrial fibrillation Previous
Item
previous ablation procedure for af
boolean
C2702800 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Follow-up Completion Unwilling | Follow-up Completion Unable
Item
unwillingness or inability to complete the required follow up arrangements
boolean
C3274571 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C3274571 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Longstanding persistent atrial fibrillation Duration | Sinus rhythm Following Electric Countershock
Item
presence of long standing persistent af with continuous af longer than 12 months. this includes patients in whom sinus rhythm may have been maintained following electrical cardioversion for a period of less than 1 week at a stretch.
boolean
C3873617 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0232201 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C0013778 (UMLS CUI [2,3])
Typical atrial flutter
Item
documented typical atrial flutter
boolean
C3264370 (UMLS CUI [1])
Replacement of mitral valve | Structural Heart Abnormality Severe
Item
prior prosthetic mitral valve replacement or severe structural cardiac abnormality
boolean
C0026268 (UMLS CUI [1])
C3274789 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Medical contraindication Amiodarone | Intolerance to Amiodarone | Medical contraindication Flecainide | Intolerance to Flecainide
Item
contraindications and/ or prior intolerance to both amiodarone and flecainide.
boolean
C1301624 (UMLS CUI [1,1])
C0002598 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0002598 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0016229 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0016229 (UMLS CUI [4,2])
Cause Reversible Atrial Fibrillation
Item
reversible cause for atrial fibrillation
boolean
C0015127 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
Hypertrophic Cardiomyopathy | Cardiomyopathy Infiltrating
Item
known hypertrophic or infiltrative cardiomyopathy
boolean
C0007194 (UMLS CUI [1])
C0878544 (UMLS CUI [2,1])
C0332448 (UMLS CUI [2,2])
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