ID

33324

Beschreibung

FIRM as a Stand-alone Procedure in the Treatment of Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT02101541

Link

https://clinicaltrials.gov/show/NCT02101541

Stichworte

Versionen (1)
  1. 05.12.18 05.12.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. Dezember 2018

DOI

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Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02101541

Englisch

Eligibility Atrial Fibrillation NCT02101541

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
paroxysmal atrial fibrillation despite of at least one class i or class iii antiarrhythmic drug and/or previous conventional ablation (pulmonary vein isolation).
Beschreibung

Paroxysmal atrial fibrillation | Anti-Arrhythmia Agents Class Quantity | Ablation conventional | Pulmonary vein isolation

Datentyp

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2,1]
C0003195
UMLS CUI [2,2]
C0456387
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0547070
UMLS CUI [3,2]
C0439858
UMLS CUI [4]
C3544330
at least one episode of paroxysmal atrial fibrillation should be documented by rhythm strip, ecg or implanted monitor during the last 6 months prior to ablation.
Beschreibung

Paroxysmal atrial fibrillation Episode Quantity Rhythm strip. | Paroxysmal atrial fibrillation Episode Quantity ECG | Paroxysmal atrial fibrillation Episode Quantity Monitor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0235480
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0547239
UMLS CUI [2,1]
C0235480
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C1623258
UMLS CUI [3,1]
C0235480
UMLS CUI [3,2]
C0332189
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0181904
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant structural heart disease (including symptomatic coronary heart disease; prosthetic mitral or tricuspid valve; congenital heart disease where abnormality or its correction prohibits or increases the risk of ablation).
Beschreibung

Structural disorder of heart | Coronary heart disease Symptomatic | Mitral valve prosthesis | Tricuspid Valve Prostheses | Congenital heart disease Risk Ablation

Datentyp

boolean

Alias
UMLS CUI [1]
C1290384
UMLS CUI [2,1]
C0010068
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C0182494
UMLS CUI [4]
C1322659
UMLS CUI [5,1]
C0152021
UMLS CUI [5,2]
C0035647
UMLS CUI [5,3]
C0547070
intracardiac thrombus, tumor or dense contrast on tee.
Beschreibung

Intracardiac thrombus TEE | Tumor intracardiac TEE | Contrast Dense TEE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0876998
UMLS CUI [1,2]
C0206054
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0729936
UMLS CUI [2,3]
C0206054
UMLS CUI [3,1]
C0009924
UMLS CUI [3,2]
C0439794
UMLS CUI [3,3]
C0206054
contraindication to anticoagulant therapy (heparin, warfarin, dabigatran and rivaroxaban).
Beschreibung

Medical contraindication Anticoagulant therapy | Medical contraindication Heparin | Medical contraindication Warfarin | Medical contraindication Dabigatran | Medical contraindication Rivaroxaban

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0150457
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0019134
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0043031
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C2348066
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C1739768
anaphylactic allergy to contrast media.
Beschreibung

Anaphylaxis reaction to contrast material

Datentyp

boolean

Alias
UMLS CUI [1]
C2215729
poor general health resulting from other disease.
Beschreibung

General health poor Due to Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1277248
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0012634
inability or refusal to provide written informed consent for the study.
Beschreibung

Informed Consent Unable | Informed Consent Refused

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1705116
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Ähnliche Modelle

Eligibility Atrial Fibrillation NCT02101541

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Paroxysmal atrial fibrillation | Anti-Arrhythmia Agents Class Quantity | Ablation conventional | Pulmonary vein isolation
Item
paroxysmal atrial fibrillation despite of at least one class i or class iii antiarrhythmic drug and/or previous conventional ablation (pulmonary vein isolation).
boolean
C0235480 (UMLS CUI [1])
C0003195 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0547070 (UMLS CUI [3,1])
C0439858 (UMLS CUI [3,2])
C3544330 (UMLS CUI [4])
Paroxysmal atrial fibrillation Episode Quantity Rhythm strip. | Paroxysmal atrial fibrillation Episode Quantity ECG | Paroxysmal atrial fibrillation Episode Quantity Monitor
Item
at least one episode of paroxysmal atrial fibrillation should be documented by rhythm strip, ecg or implanted monitor during the last 6 months prior to ablation.
boolean
C0235480 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0547239 (UMLS CUI [1,4])
C0235480 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1623258 (UMLS CUI [2,4])
C0235480 (UMLS CUI [3,1])
C0332189 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0181904 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Structural disorder of heart | Coronary heart disease Symptomatic | Mitral valve prosthesis | Tricuspid Valve Prostheses | Congenital heart disease Risk Ablation
Item
significant structural heart disease (including symptomatic coronary heart disease; prosthetic mitral or tricuspid valve; congenital heart disease where abnormality or its correction prohibits or increases the risk of ablation).
boolean
C1290384 (UMLS CUI [1])
C0010068 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0182494 (UMLS CUI [3])
C1322659 (UMLS CUI [4])
C0152021 (UMLS CUI [5,1])
C0035647 (UMLS CUI [5,2])
C0547070 (UMLS CUI [5,3])
Intracardiac thrombus TEE | Tumor intracardiac TEE | Contrast Dense TEE
Item
intracardiac thrombus, tumor or dense contrast on tee.
boolean
C0876998 (UMLS CUI [1,1])
C0206054 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C0729936 (UMLS CUI [2,2])
C0206054 (UMLS CUI [2,3])
C0009924 (UMLS CUI [3,1])
C0439794 (UMLS CUI [3,2])
C0206054 (UMLS CUI [3,3])
Medical contraindication Anticoagulant therapy | Medical contraindication Heparin | Medical contraindication Warfarin | Medical contraindication Dabigatran | Medical contraindication Rivaroxaban
Item
contraindication to anticoagulant therapy (heparin, warfarin, dabigatran and rivaroxaban).
boolean
C1301624 (UMLS CUI [1,1])
C0150457 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0043031 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C2348066 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C1739768 (UMLS CUI [5,2])
Anaphylaxis reaction to contrast material
Item
anaphylactic allergy to contrast media.
boolean
C2215729 (UMLS CUI [1])
General health poor Due to Disease
Item
poor general health resulting from other disease.
boolean
C1277248 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
Informed Consent Unable | Informed Consent Refused
Item
inability or refusal to provide written informed consent for the study.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
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