ID

31466

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01058980

Nyckelord

Versioner (1)
  1. 2018-08-25 2018-08-25 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

25 augusti 2018

DOI

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Creative Commons BY 4.0
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Eligibility Paroxysmal Atrial Fibrillation NCT01058980

Engelsk

Eligibility Paroxysmal Atrial Fibrillation NCT01058980

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age more than 18 years
Beskrivning

Age

Datatyp

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
Beskrivning

Paroxysmal atrial fibrillation Disease length | Episode Symptomatic Quantity

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications to oral anticoagulants
Beskrivning

Medical contraindication Oral anticoagulants

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Intracardiac thrombus

Datatyp

boolean

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

Atrial Fibrillation Due to Cause Reversible

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Pregnancy

Datatyp

boolean

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

Asthma | Bronchial Spasm | Adverse reactions Adenosine

Datatyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0006266
UMLS CUI [3,1]
C0559546
UMLS CUI [3,2]
C0001443
Tillbaka till toppen

Similar models

Eligibility Paroxysmal Atrial Fibrillation NCT01058980

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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