ID

14587

Beschreibung

Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT00111488

Link

https://clinicaltrials.gov/show/NCT00111488

Stichworte

Versionen (1)
  1. 22.04.16 22.04.16 -
Hochgeladen am

22. April 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00111488

Englisch

Eligibility Atrial Fibrillation NCT00111488

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient age >= 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
documented permanent af (for at least three months)
Beschreibung

Permanent atrial fibrillation

Datentyp

boolean

Alias
UMLS CUI [1]
C2586056
scheduled for an open chest cardiac surgery for the primary indication of mitral valve repair or replacement
Beschreibung

Cardiac Surgery procedures Chest Open approach | Heart - Mitral Valve: Repair | Replacement of mitral valve

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C0817096
UMLS CUI [1,3]
C0348025
UMLS CUI [2]
C0869755
UMLS CUI [3]
C0026268
has been informed of the nature of the study, agrees to its provisions, and provided written informed consent, which was approved by the appropriate institutional review board/ethics committee of the respective clinical site
Beschreibung

Informed Consent | Institutional Review Board Approval | Ethics Committees, Research

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C2346499
UMLS CUI [3]
C0086911
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
cerebral vascular accident (cva, stroke) or transient ischemic attack (tia) within the previous 6 months
Beschreibung

Cerebrovascular accident | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
myocardial infarction within the previous 6 weeks
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
documented history of pulmonary vein stenosis
Beschreibung

Pulmonary vein stenosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0340756
previous ablation attempt for af
Beschreibung

Ablation Attempt | Atrial Fibrillation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0547070
UMLS CUI [1,2]
C1516084
UMLS CUI [2]
C0004238
previous thoracic procedures
Beschreibung

Thoracic Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0524832
left atrial size > 7.0 cm
Beschreibung

Left atrial structure Size

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0456389
left ventricular ejection fraction < 30%
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
presence of left atrial or left atrial appendage thrombi
Beschreibung

Thrombus of left atrium | echocardiography: thrombus formation of left atrial appendage

Datentyp

boolean

Alias
UMLS CUI [1]
C3532827
UMLS CUI [2]
C2040341
esophageal fistula or other stricture, untreated esophagitis, varices, dysphagia or odynophagia contraindicating transesophageal echocardiography
Beschreibung

Esophageal Fistula | Esophageal Stenosis | Esophagitis | Esophageal Varices | Deglutition Disorders | Swallowing painful | Medical contraindication Echocardiography, Transesophageal

Datentyp

boolean

Alias
UMLS CUI [1]
C0014856
UMLS CUI [2]
C0014866
UMLS CUI [3]
C0014868
UMLS CUI [4]
C0014867
UMLS CUI [5]
C0011168
UMLS CUI [6]
C0221150
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0206054
known allergy or contraindication to warfarin therapy
Beschreibung

Hypersensitivity Warfarin Therapeutic procedure | Medical contraindication Warfarin Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0043031
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0043031
UMLS CUI [2,3]
C0087111
known allergy or contraindication to antiarrhythmic (classes ia, ic, iii) therapy
Beschreibung

Hypersensitivity Class Ia antiarrhythmic drug | Hypersensitivity Class Ic antiarrhythmic drug | Hypersensitivity Class III antiarrhythmic drug | Medical contraindication Class Ia antiarrhythmic drug | Medical contraindication Class Ic antiarrhythmic drug | Medical contraindication Class III antiarrhythmic drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304503
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0304505
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0360703
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0304503
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0304505
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0360703
other comorbidity with reduced life expectancy of less than 1 year or protocol noncompliance that would limit follow-up
Beschreibung

Comorbidity Reduced life expectancy | Compliance behavior Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1858274
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0439801
geographically remote or unable to return for follow-up examinations
Beschreibung

Geographical area Remote | Unable Follow-up

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681784
UMLS CUI [1,2]
C0205157
UMLS CUI [2,1]
C1299582
UMLS CUI [2,2]
C1522577
pregnant or planning to become pregnant during the study
Beschreibung

Pregnancy | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
enrolled in any concurrent study, without guidant written approval, that may confound the results of the study
Beschreibung

Study Subject Participation Status Affecting research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0683954
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Ähnliche Modelle

Eligibility Atrial Fibrillation NCT00111488

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient age >= 18 years
boolean
C0001779 (UMLS CUI [1])
Permanent atrial fibrillation
Item
documented permanent af (for at least three months)
boolean
C2586056 (UMLS CUI [1])
Cardiac Surgery procedures Chest Open approach | Heart - Mitral Valve: Repair | Replacement of mitral valve
Item
scheduled for an open chest cardiac surgery for the primary indication of mitral valve repair or replacement
boolean
C0018821 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
C0348025 (UMLS CUI [1,3])
C0869755 (UMLS CUI [2])
C0026268 (UMLS CUI [3])
Informed Consent | Institutional Review Board Approval | Ethics Committees, Research
Item
has been informed of the nature of the study, agrees to its provisions, and provided written informed consent, which was approved by the appropriate institutional review board/ethics committee of the respective clinical site
boolean
C0021430 (UMLS CUI [1])
C2346499 (UMLS CUI [2])
C0086911 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Cerebrovascular accident | Transient Ischemic Attack
Item
cerebral vascular accident (cva, stroke) or transient ischemic attack (tia) within the previous 6 months
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Myocardial Infarction
Item
myocardial infarction within the previous 6 weeks
boolean
C0027051 (UMLS CUI [1])
Pulmonary vein stenosis
Item
documented history of pulmonary vein stenosis
boolean
C0340756 (UMLS CUI [1])
Ablation Attempt | Atrial Fibrillation
Item
previous ablation attempt for af
boolean
C0547070 (UMLS CUI [1,1])
C1516084 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2])
Thoracic Surgical Procedures
Item
previous thoracic procedures
boolean
C0524832 (UMLS CUI [1])
Left atrial structure Size
Item
left atrial size > 7.0 cm
boolean
C0225860 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
left ventricular ejection fraction < 30%
boolean
C0428772 (UMLS CUI [1])
Thrombus of left atrium | echocardiography: thrombus formation of left atrial appendage
Item
presence of left atrial or left atrial appendage thrombi
boolean
C3532827 (UMLS CUI [1])
C2040341 (UMLS CUI [2])
Esophageal Fistula | Esophageal Stenosis | Esophagitis | Esophageal Varices | Deglutition Disorders | Swallowing painful | Medical contraindication Echocardiography, Transesophageal
Item
esophageal fistula or other stricture, untreated esophagitis, varices, dysphagia or odynophagia contraindicating transesophageal echocardiography
boolean
C0014856 (UMLS CUI [1])
C0014866 (UMLS CUI [2])
C0014868 (UMLS CUI [3])
C0014867 (UMLS CUI [4])
C0011168 (UMLS CUI [5])
C0221150 (UMLS CUI [6])
C1301624 (UMLS CUI [7,1])
C0206054 (UMLS CUI [7,2])
Hypersensitivity Warfarin Therapeutic procedure | Medical contraindication Warfarin Therapeutic procedure
Item
known allergy or contraindication to warfarin therapy
boolean
C0020517 (UMLS CUI [1,1])
C0043031 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0043031 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Hypersensitivity Class Ia antiarrhythmic drug | Hypersensitivity Class Ic antiarrhythmic drug | Hypersensitivity Class III antiarrhythmic drug | Medical contraindication Class Ia antiarrhythmic drug | Medical contraindication Class Ic antiarrhythmic drug | Medical contraindication Class III antiarrhythmic drug
Item
known allergy or contraindication to antiarrhythmic (classes ia, ic, iii) therapy
boolean
C0020517 (UMLS CUI [1,1])
C0304503 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0304505 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0360703 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0304503 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C0304505 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0360703 (UMLS CUI [6,2])
Comorbidity Reduced life expectancy | Compliance behavior Limited
Item
other comorbidity with reduced life expectancy of less than 1 year or protocol noncompliance that would limit follow-up
boolean
C0009488 (UMLS CUI [1,1])
C1858274 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Geographical area Remote | Unable Follow-up
Item
geographically remote or unable to return for follow-up examinations
boolean
C0681784 (UMLS CUI [1,1])
C0205157 (UMLS CUI [1,2])
C1299582 (UMLS CUI [2,1])
C1522577 (UMLS CUI [2,2])
Pregnancy | Pregnancy, Planned
Item
pregnant or planning to become pregnant during the study
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Study Subject Participation Status Affecting research results
Item
enrolled in any concurrent study, without guidant written approval, that may confound the results of the study
boolean
C2348568 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
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