ID

34786

Descrição

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

Palavras-chave

Versões (1)
  1. 28/01/2019 28/01/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

28 de janeiro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02047279

Inglês

Eligibility Atrial Fibrillation NCT02047279

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

Informed Consent

Tipo de dados

boolean

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

Age

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

Atrial Fibrillation Duration Medical History | Atrial Fibrillation Electrocardiography

Tipo de dados

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.
Descrição

Longstanding persistent atrial fibrillation Duration

Tipo de dados

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.
Descrição

Atrial Fibrillation Duration Medical History | Atrial Fibrillation Electrocardiography

Tipo de dados

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
Descrição

Left atrium Diameter

Tipo de dados

boolean

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

Use of Cardiac rhythm Monitor

Tipo de dados

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
af is paroxysmal
Descrição

Paroxysmal atrial fibrillation

Tipo de dados

boolean

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

Atrial Fibrillation Without Indication Mitral valve operation

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Catheter ablation for atrial fibrillation Previous

Tipo de dados

boolean

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

Redo Cardiac Surgery procedure

Tipo de dados

boolean

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

Left ventricular ejection fraction

Tipo de dados

boolean

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

Life Expectancy

Tipo de dados

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
Descrição

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

Tipo de dados

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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