ID

31466

Descrição

ADenosine Following Pulmonary Vein Isolation to Target Dormant Conduction Elimination: the ADVICE Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01058980

Link

https://clinicaltrials.gov/show/NCT01058980

Palavras-chave

Versões (1)
  1. 25/08/2018 25/08/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

25 de agosto de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Paroxysmal Atrial Fibrillation NCT01058980

Inglês

Eligibility Paroxysmal Atrial Fibrillation NCT01058980

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
age more than 18 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
paroxysmal af for at least 6 months with at least 3 symptomatic episodes (using patient history) during the previous 6 months
Descrição

Paroxysmal atrial fibrillation Disease length | Episode Symptomatic Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0235480
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C1265611
patients must be felt to be candidates for af ablation based on af that is symptomatic and refractory or intolerant to at least one class 1 or 3 antiarrhythmic agent.
Descrição

Patients Appropriate Ablation Atrial Fibrillation | ATRIAL FIBRILLATION SYMPTOMATIC | Atrial Fibrillation Unresponsive to Treatment | Intolerance to Anti-Arrhythmia Agents Class Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0547070
UMLS CUI [1,4]
C0004238
UMLS CUI [2]
C0741283
UMLS CUI [3,1]
C0004238
UMLS CUI [3,2]
C0205269
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0003195
UMLS CUI [4,3]
C0456387
UMLS CUI [4,4]
C1265611
documentation of at least one episode of af on 12 lead ecg, ttm or holter monitor within 12 months of randomization in the trial
Descrição

Atrial Fibrillation Episode Quantity 12 lead ECG | Other Coding | Atrial Fibrillation Episode Quantity Holter Electrocardiography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0430456
UMLS CUI [2]
C3846158
UMLS CUI [3,1]
C0004238
UMLS CUI [3,2]
C0332189
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0013801
patients must be on continuous anticoagulation with warfarin (inr 2-3) or fractionated subcutaneous heparin for >4 weeks prior to the ablation or they have undergone a recent (less than 48 hours before planned ablation) transoesophageal echocardiogram to exclude left atrial thrombus.
Descrição

Anticoagulation Therapy | Warfarin | International Normalized Ratio | Subcutaneous heparin Fractionated | Transesophageal Echocardiography Excludes Thrombus of left atrium

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2]
C0043031
UMLS CUI [3]
C0525032
UMLS CUI [4,1]
C0353681
UMLS CUI [4,2]
C1979893
UMLS CUI [5,1]
C0206054
UMLS CUI [5,2]
C0332196
UMLS CUI [5,3]
C3532827
patients must provide written informed consent to participate in the clinical trial.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications to oral anticoagulants
Descrição

Medical contraindication Oral anticoagulants

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0354604
history of any previous ablation or surgical maze for af
Descrição

Ablation Atrial Fibrillation In the past | Surgical Maze Procedure In the past

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0547070
UMLS CUI [1,2]
C0004238
UMLS CUI [1,3]
C1444637
UMLS CUI [2,1]
C3272262
UMLS CUI [2,2]
C1444637
intracardiac thrombus
Descrição

Intracardiac thrombus

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0876998
af due to reversible cause
Descrição

Atrial Fibrillation Due to Cause Reversible

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0205343
patients with left atrial size > 55mm or significant mitral valve disease (moderate or severe mitral stenosis or regurgitation)
Descrição

Left atrium Size | Diseases of mitral valve | MITRAL STENOSIS MODERATE | Mitral Valve Stenosis Severe | Mitral regurgitation Moderate | Mitral regurgitation Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0456389
UMLS CUI [2]
C0026265
UMLS CUI [3]
C0746601
UMLS CUI [4,1]
C0026269
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0026266
UMLS CUI [5,2]
C0205081
UMLS CUI [6,1]
C0026266
UMLS CUI [6,2]
C0205082
pregnancy
Descrição

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
asthma, history of bronchospasm or known adverse reaction to adenosine
Descrição

Asthma | Bronchial Spasm | Adverse reactions Adenosine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0006266
UMLS CUI [3,1]
C0559546
UMLS CUI [3,2]
C0001443
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Similar models

Eligibility Paroxysmal Atrial Fibrillation NCT01058980

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age more than 18 years
boolean
C0001779 (UMLS CUI [1])
Paroxysmal atrial fibrillation Disease length | Episode Symptomatic Quantity
Item
paroxysmal af for at least 6 months with at least 3 symptomatic episodes (using patient history) during the previous 6 months
boolean
C0235480 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0332189 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Patients Appropriate Ablation Atrial Fibrillation | ATRIAL FIBRILLATION SYMPTOMATIC | Atrial Fibrillation Unresponsive to Treatment | Intolerance to Anti-Arrhythmia Agents Class Quantity
Item
patients must be felt to be candidates for af ablation based on af that is symptomatic and refractory or intolerant to at least one class 1 or 3 antiarrhythmic agent.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0547070 (UMLS CUI [1,3])
C0004238 (UMLS CUI [1,4])
C0741283 (UMLS CUI [2])
C0004238 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0003195 (UMLS CUI [4,2])
C0456387 (UMLS CUI [4,3])
C1265611 (UMLS CUI [4,4])
Atrial Fibrillation Episode Quantity 12 lead ECG | Other Coding | Atrial Fibrillation Episode Quantity Holter Electrocardiography
Item
documentation of at least one episode of af on 12 lead ecg, ttm or holter monitor within 12 months of randomization in the trial
boolean
C0004238 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0430456 (UMLS CUI [1,4])
C3846158 (UMLS CUI [2])
C0004238 (UMLS CUI [3,1])
C0332189 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0013801 (UMLS CUI [3,4])
Anticoagulation Therapy | Warfarin | International Normalized Ratio | Subcutaneous heparin Fractionated | Transesophageal Echocardiography Excludes Thrombus of left atrium
Item
patients must be on continuous anticoagulation with warfarin (inr 2-3) or fractionated subcutaneous heparin for >4 weeks prior to the ablation or they have undergone a recent (less than 48 hours before planned ablation) transoesophageal echocardiogram to exclude left atrial thrombus.
boolean
C0003281 (UMLS CUI [1])
C0043031 (UMLS CUI [2])
C0525032 (UMLS CUI [3])
C0353681 (UMLS CUI [4,1])
C1979893 (UMLS CUI [4,2])
C0206054 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C3532827 (UMLS CUI [5,3])
Informed Consent
Item
patients must provide written informed consent to participate in the clinical trial.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Oral anticoagulants
Item
contraindications to oral anticoagulants
boolean
C1301624 (UMLS CUI [1,1])
C0354604 (UMLS CUI [1,2])
Ablation Atrial Fibrillation In the past | Surgical Maze Procedure In the past
Item
history of any previous ablation or surgical maze for af
boolean
C0547070 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C1444637 (UMLS CUI [1,3])
C3272262 (UMLS CUI [2,1])
C1444637 (UMLS CUI [2,2])
Intracardiac thrombus
Item
intracardiac thrombus
boolean
C0876998 (UMLS CUI [1])
Atrial Fibrillation Due to Cause Reversible
Item
af due to reversible cause
boolean
C0004238 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0205343 (UMLS CUI [1,4])
Left atrium Size | Diseases of mitral valve | MITRAL STENOSIS MODERATE | Mitral Valve Stenosis Severe | Mitral regurgitation Moderate | Mitral regurgitation Severe
Item
patients with left atrial size > 55mm or significant mitral valve disease (moderate or severe mitral stenosis or regurgitation)
boolean
C0225860 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0026265 (UMLS CUI [2])
C0746601 (UMLS CUI [3])
C0026269 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0026266 (UMLS CUI [5,1])
C0205081 (UMLS CUI [5,2])
C0026266 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Asthma | Bronchial Spasm | Adverse reactions Adenosine
Item
asthma, history of bronchospasm or known adverse reaction to adenosine
boolean
C0004096 (UMLS CUI [1])
C0006266 (UMLS CUI [2])
C0559546 (UMLS CUI [3,1])
C0001443 (UMLS CUI [3,2])
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