ID

34786

Beschrijving

Ablation and Left Atrium Reduction During Mitral Valve Surgery for Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT02047279

Link

https://clinicaltrials.gov/show/NCT02047279

Trefwoorden

Versies (1)
  1. 28-01-19 28-01-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

28 januari 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02047279

Engels

Eligibility Atrial Fibrillation NCT02047279

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
able to sign informed consent and release of medical information forms
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
age ≥ 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
clinical indications for mitral valve surgery for organic mitral valve disease note: may include need for surgical management of functional tricuspid regurgitation or patent foramen ovale. surgical intervention may be performed via sternotomy or minimally invasive procedure.
Beschrijving

Indication Mitral valve operation | Diseases of mitral valve | Operative Surgical Procedures Tricuspid regurgitation | Operative Surgical Procedures Patent Foramen Ovale | Sternotomy | Minimally Invasive Surgical Procedures

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0519382
UMLS CUI [2]
C0026265
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0040961
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0016522
UMLS CUI [5]
C0185792
UMLS CUI [6]
C0282624
a) persistent atrial fibrillation (af) within 6 months prior to randomization, defined as non self-terminating af lasting greater than 7 days but no more than one year, or lasting less than 7 days but necessitating pharmacologic or electrical cardioversion.
Beschrijving

Persistent atrial fibrillation | Patient need for Pharmacological cardioversion | Patient need for Electrical cardioversion

Datatype

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C1963873
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0013778
duration of af must be documented by medical history and presence of af must be documented by a direct electrocardiographic assessment within 6 months prior to randomization.
Beschrijving

Atrial Fibrillation Duration Medical History | Atrial Fibrillation Electrocardiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C1623258
b) longstanding persistent af is defined as continuous af of greater than one year duration.
Beschrijving

Longstanding persistent atrial fibrillation Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C3873617
UMLS CUI [1,2]
C0449238
duration of af must be documented by medical history and presence of af must be documented by a direct electrocardiographic assessment upon arrival in the or.
Beschrijving

Atrial Fibrillation Duration Medical History | Atrial Fibrillation Electrocardiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C1623258
left atrial diameter > 65mm
Beschrijving

Left atrium Diameter

Datatype

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C1301886
able to use heart rhythm monitor
Beschrijving

Use of Cardiac rhythm Monitor

Datatype

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0232187
UMLS CUI [1,3]
C0181904
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
af is paroxysmal
Beschrijving

Paroxysmal atrial fibrillation

Datatype

boolean

Alias
UMLS CUI [1]
C0235480
af without indication for mitral valve surgery
Beschrijving

Atrial Fibrillation Without Indication Mitral valve operation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C3146298
UMLS CUI [1,4]
C0519382
concomitant coronary artery bypass grafting (cabg), aortic arch or aortic valve procedure
Beschrijving

Coronary Artery Bypass Surgery | Aortic arch procedure | Aortic valve procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2,1]
C0003489
UMLS CUI [2,2]
C0184661
UMLS CUI [3,1]
C0003501
UMLS CUI [3,2]
C0184661
previous catheter ablation for af
Beschrijving

Catheter ablation for atrial fibrillation Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C0205156
redo cardiac surgery
Beschrijving

Redo Cardiac Surgery procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0439617
UMLS CUI [1,2]
C0018821
left ventricle ejection fraction (lv ef) < 35%
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
life expectancy of less than one year
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
mental impairment or other conditions that may not allow subject to understand the nature, significance, and scope of study
Beschrijving

Mental impairment Preventing Comprehension Study Protocol | Condition Preventing Comprehension Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0683322
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0162340
UMLS CUI [2,4]
C2348563
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Similar models

Eligibility Atrial Fibrillation NCT02047279

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
able to sign informed consent and release of medical information forms
boolean
C0021430 (UMLS CUI [1])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Indication Mitral valve operation | Diseases of mitral valve | Operative Surgical Procedures Tricuspid regurgitation | Operative Surgical Procedures Patent Foramen Ovale | Sternotomy | Minimally Invasive Surgical Procedures
Item
clinical indications for mitral valve surgery for organic mitral valve disease note: may include need for surgical management of functional tricuspid regurgitation or patent foramen ovale. surgical intervention may be performed via sternotomy or minimally invasive procedure.
boolean
C3146298 (UMLS CUI [1,1])
C0519382 (UMLS CUI [1,2])
C0026265 (UMLS CUI [2])
C0543467 (UMLS CUI [3,1])
C0040961 (UMLS CUI [3,2])
C0543467 (UMLS CUI [4,1])
C0016522 (UMLS CUI [4,2])
C0185792 (UMLS CUI [5])
C0282624 (UMLS CUI [6])
Persistent atrial fibrillation | Patient need for Pharmacological cardioversion | Patient need for Electrical cardioversion
Item
a) persistent atrial fibrillation (af) within 6 months prior to randomization, defined as non self-terminating af lasting greater than 7 days but no more than one year, or lasting less than 7 days but necessitating pharmacologic or electrical cardioversion.
boolean
C2585653 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C1963873 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C0013778 (UMLS CUI [3,2])
Atrial Fibrillation Duration Medical History | Atrial Fibrillation Electrocardiography
Item
duration of af must be documented by medical history and presence of af must be documented by a direct electrocardiographic assessment within 6 months prior to randomization.
boolean
C0004238 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0004238 (UMLS CUI [2,1])
C1623258 (UMLS CUI [2,2])
Longstanding persistent atrial fibrillation Duration
Item
b) longstanding persistent af is defined as continuous af of greater than one year duration.
boolean
C3873617 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Atrial Fibrillation Duration Medical History | Atrial Fibrillation Electrocardiography
Item
duration of af must be documented by medical history and presence of af must be documented by a direct electrocardiographic assessment upon arrival in the or.
boolean
C0004238 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0004238 (UMLS CUI [2,1])
C1623258 (UMLS CUI [2,2])
Left atrium Diameter
Item
left atrial diameter > 65mm
boolean
C0225860 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Use of Cardiac rhythm Monitor
Item
able to use heart rhythm monitor
boolean
C1524063 (UMLS CUI [1,1])
C0232187 (UMLS CUI [1,2])
C0181904 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Paroxysmal atrial fibrillation
Item
af is paroxysmal
boolean
C0235480 (UMLS CUI [1])
Atrial Fibrillation Without Indication Mitral valve operation
Item
af without indication for mitral valve surgery
boolean
C0004238 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0519382 (UMLS CUI [1,4])
Coronary Artery Bypass Surgery | Aortic arch procedure | Aortic valve procedure
Item
concomitant coronary artery bypass grafting (cabg), aortic arch or aortic valve procedure
boolean
C0010055 (UMLS CUI [1])
C0003489 (UMLS CUI [2,1])
C0184661 (UMLS CUI [2,2])
C0003501 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
Catheter ablation for atrial fibrillation Previous
Item
previous catheter ablation for af
boolean
C2702800 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Redo Cardiac Surgery procedure
Item
redo cardiac surgery
boolean
C0439617 (UMLS CUI [1,1])
C0018821 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
left ventricle ejection fraction (lv ef) < 35%
boolean
C0428772 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of less than one year
boolean
C0023671 (UMLS CUI [1])
Mental impairment Preventing Comprehension Study Protocol | Condition Preventing Comprehension Study Protocol
Item
mental impairment or other conditions that may not allow subject to understand the nature, significance, and scope of study
boolean
C0683322 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0162340 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
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