ID

37474

Beschreibung

Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01182441

Link

https://clinicaltrials.gov/show/NCT01182441

Stichworte

Versionen (1)
  1. 31.07.19 31.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

31. Juli 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Atrial Fibrillation NCT01182441

Englisch

Eligibility Atrial Fibrillation NCT01182441

1 Formulare  
Criteria
Beschreibung

Criteria

paroxysmal, persistent or permanent non-valvular af
Beschreibung

Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Permanent atrial fibrillation | Heart Valve Involvement Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C2585653
UMLS CUI [3]
C2586056
UMLS CUI [4,1]
C0018826
UMLS CUI [4,2]
C1314939
UMLS CUI [4,3]
C0332197
eligible for long-term warfarin therapy
Beschreibung

Eligibility Warfarin therapy Long-term

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C4303340
UMLS CUI [1,3]
C0443252
eligible to come off warfarin therapy
Beschreibung

Eligibility Warfarin therapy Discontinue

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C4303340
UMLS CUI [1,3]
C1444662
calculated chads2 score of 2 or greater. also patients with a chads2 score of 1 may be included if any of the following apply:
Beschreibung

CHADS2 score

Datentyp

boolean

Alias
UMLS CUI [1]
C2585876
female age 75 or older
Beschreibung

Gender | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
baseline lvef ≥ 30 and < 35%
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
aged 65-74 and has diabetes or coronary artery disease
Beschreibung

Age | Diabetes Mellitus | Coronary Artery Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011849
UMLS CUI [3]
C1956346
aged 65 or greater and has congestive heart failure
Beschreibung

Age | Congestive heart failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0018802
key exclusion criteria:
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
contraindicated/allergic to aspirin
Beschreibung

Medical contraindication Aspirin | Aspirin allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0004057
UMLS CUI [2]
C0004058
indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment
Beschreibung

Indication Clopidogrel | Clopidogrel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0070166
UMLS CUI [2]
C0070166
history of atrial septal repair or has an asd/pfo device
Beschreibung

Atrioseptoplasty | ASD Device | PFO Device

Datentyp

boolean

Alias
UMLS CUI [1]
C0189965
UMLS CUI [2,1]
C0018817
UMLS CUI [2,2]
C0025080
UMLS CUI [3,1]
C0016522
UMLS CUI [3,2]
C0025080
implanted mechanical valve prosthesis
Beschreibung

Mechanical heart valve prosthesis Implanted

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3873910
UMLS CUI [1,2]
C0021102
nyha class iv chf
Beschreibung

Congestive heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
resting heart rate > 110 bpm
Beschreibung

Resting heart rate

Datentyp

boolean

Alias
UMLS CUI [1]
C1821417
participated previously in the protect af or cap registry studies
Beschreibung

Study Subject Participation Status | Clinical Trials Specified

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
key echo exclusion criteria:
Beschreibung

Echocardiography Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C1542147
lvef < 30%
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
existing pericardial effusion > 2mm
Beschreibung

Pericardial effusion

Datentyp

boolean

Alias
UMLS CUI [1]
C0031039
high risk pfo
Beschreibung

High risk PFO

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0016522
significant mitral valve stenosis
Beschreibung

Mitral Valve Stenosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0026269
complex atheroma with mobile plaque of the descending aorta and/or aortic arch
Beschreibung

Atheroma Complex | Plaque Descending aorta | Plaque Aortic arch

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0264956
UMLS CUI [1,2]
C0439855
UMLS CUI [2,1]
C2936350
UMLS CUI [2,2]
C0011666
UMLS CUI [3,1]
C2936350
UMLS CUI [3,2]
C0003489
cardiac tumor
Beschreibung

Heart Neoplasm

Datentyp

boolean

Alias
UMLS CUI [1]
C0018809
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Atrial Fibrillation NCT01182441

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Permanent atrial fibrillation | Heart Valve Involvement Absent
Item
paroxysmal, persistent or permanent non-valvular af
boolean
C0235480 (UMLS CUI [1])
C2585653 (UMLS CUI [2])
C2586056 (UMLS CUI [3])
C0018826 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Eligibility Warfarin therapy Long-term
Item
eligible for long-term warfarin therapy
boolean
C1548635 (UMLS CUI [1,1])
C4303340 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
Eligibility Warfarin therapy Discontinue
Item
eligible to come off warfarin therapy
boolean
C1548635 (UMLS CUI [1,1])
C4303340 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
CHADS2 score
Item
calculated chads2 score of 2 or greater. also patients with a chads2 score of 1 may be included if any of the following apply:
boolean
C2585876 (UMLS CUI [1])
Gender | Age
Item
female age 75 or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Left ventricular ejection fraction
Item
baseline lvef ≥ 30 and < 35%
boolean
C0428772 (UMLS CUI [1])
Age | Diabetes Mellitus | Coronary Artery Disease
Item
aged 65-74 and has diabetes or coronary artery disease
boolean
C0001779 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C1956346 (UMLS CUI [3])
Age | Congestive heart failure
Item
aged 65 or greater and has congestive heart failure
boolean
C0001779 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Medical contraindication Aspirin | Aspirin allergy
Item
contraindicated/allergic to aspirin
boolean
C1301624 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0004058 (UMLS CUI [2])
Indication Clopidogrel | Clopidogrel
Item
indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment
boolean
C3146298 (UMLS CUI [1,1])
C0070166 (UMLS CUI [1,2])
C0070166 (UMLS CUI [2])
Atrioseptoplasty | ASD Device | PFO Device
Item
history of atrial septal repair or has an asd/pfo device
boolean
C0189965 (UMLS CUI [1])
C0018817 (UMLS CUI [2,1])
C0025080 (UMLS CUI [2,2])
C0016522 (UMLS CUI [3,1])
C0025080 (UMLS CUI [3,2])
Mechanical heart valve prosthesis Implanted
Item
implanted mechanical valve prosthesis
boolean
C3873910 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
Congestive heart failure New York Heart Association Classification
Item
nyha class iv chf
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Resting heart rate
Item
resting heart rate > 110 bpm
boolean
C1821417 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trials Specified
Item
participated previously in the protect af or cap registry studies
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Echocardiography Exclusion Criteria Main
Item
key echo exclusion criteria:
boolean
C0013516 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
Left ventricular ejection fraction
Item
lvef < 30%
boolean
C0428772 (UMLS CUI [1])
Pericardial effusion
Item
existing pericardial effusion > 2mm
boolean
C0031039 (UMLS CUI [1])
High risk PFO
Item
high risk pfo
boolean
C0332167 (UMLS CUI [1,1])
C0016522 (UMLS CUI [1,2])
Mitral Valve Stenosis
Item
significant mitral valve stenosis
boolean
C0026269 (UMLS CUI [1])
Atheroma Complex | Plaque Descending aorta | Plaque Aortic arch
Item
complex atheroma with mobile plaque of the descending aorta and/or aortic arch
boolean
C0264956 (UMLS CUI [1,1])
C0439855 (UMLS CUI [1,2])
C2936350 (UMLS CUI [2,1])
C0011666 (UMLS CUI [2,2])
C2936350 (UMLS CUI [3,1])
C0003489 (UMLS CUI [3,2])
Heart Neoplasm
Item
cardiac tumor
boolean
C0018809 (UMLS CUI [1])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video