ID

37452

Descrição

Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00903370

Link

https://clinicaltrials.gov/show/NCT00903370

Palavras-chave

Versões (1)
  1. 29/07/2019 29/07/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

29 de julho de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00903370

Inglês

Eligibility Atrial Fibrillation NCT00903370

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 | Release of information consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C3166272
age ≥ 18 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
clinical indications for mitral valve surgery for the following:
Descrição

Indication Mitral valve operation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0519382
1. organic mitral valve disease; or
Descrição

Organic disease Mitral Valve

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0683324
UMLS CUI [1,2]
C0026264
2. functional non-ischemic mitral regurgitation; or
Descrição

Functional mitral regurgitation | Ischemia Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0340369
UMLS CUI [2,1]
C0022116
UMLS CUI [2,2]
C0332196
3. ischemic mitral regurgitation with evidence of concomitant structural mitral valve disease
Descrição

Ischaemic mitral regurgitation | Disease of mitral valve structural

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4087284
UMLS CUI [2,1]
C0026265
UMLS CUI [2,2]
C0678594
note: may include need for surgical management of functional tricuspid regurgitation or patent foramen ovale. may also include concomitant cabg, aortic arch or aortic valve procedure. surgical intervention may be performed via sternotomy or minimally invasive procedure.
Descrição

Patient need for Surgical Management Functional tricuspid regurgitation | Patient need for Surgical Management Patent Foramen Ovale | Coronary Artery Bypass Surgery | Aortic arch Interventional procedure | Aortic valve Interventional procedure | Sternotomy | Minimally Invasive Surgical Procedures

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C1515089
UMLS CUI [1,3]
C0340392
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C1515089
UMLS CUI [2,3]
C0016522
UMLS CUI [3]
C0010055
UMLS CUI [4,1]
C0003489
UMLS CUI [4,2]
C0184661
UMLS CUI [5,1]
C0003501
UMLS CUI [5,2]
C0184661
UMLS CUI [6]
C0185792
UMLS CUI [7]
C0282624
a) persistent 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 Duration | Patient need for Pharmacological cardioversion | Patient need for Electric Countershock

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2585653
UMLS CUI [1,2]
C0449238
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
Descrição

Atrial Fibrillation Duration Medical History

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0262926
presence of af must be documented by a direct electrocardiographic assessment within 6 months prior to randomization.
Descrição

Atrial Fibrillation Electrocardiography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
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
Descrição

Atrial Fibrillation Duration Medical History

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0262926
presence of af must be documented by a direct electrocardiographic assessment upon arrival in the or.
Descrição

Atrial Fibrillation Electrocardiography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C1623258
able to use heart rhythm monitor
Descrição

Monitor heart rate and rhythm

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0513462
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. af without indication for mitral valve surgery 2. af is paroxysmal 3. evidence of left atrial thrombus by intra-operative tee 4. evidence of active infection 5. mental impairment or other conditions that may not allow subject to understand the nature, significance, and scope of study 6. surgical management of hypertrophic obstructive cardiomyopathy 7. previous catheter ablation for af 8. life expectancy of less than one year 9. absolute contraindications for anticoagulation therapy 10. enrollment in concomitant drug or device trials 11. uncontrolled hypo- or hyperthyroidism 12. fev1 < 30% of predicted value and/or need for home oxygen therapy 13. women who are pregnant as evidenced by positive pregnancy test 14. women of childbearing age who do not agree to be on adequate birth control throughout the period of the trial.
Descrição

Atrial Fibrillation | Indication Absent Mitral valve operation | Paroxysmal atrial fibrillation | Thrombus of left atrium Transesophageal Echocardiography Intraoperative | Communicable Disease | Mental impairment | Study Protocol Comprehension Unable | Surgical Management Hypertrophic Cardiomyopathy | Catheter ablation for atrial fibrillation | Life Expectancy | Medical contraindication Anticoagulation Therapy | Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Hypothyroidism Uncontrolled | Hyperthyroidism Uncontrolled | Percent predicted FEV1 | Patient need for Home oxygen therapy | Pregnancy Pregnancy test positive | Childbearing Potential Contraceptive methods Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0519382
UMLS CUI [3]
C0235480
UMLS CUI [4,1]
C3532827
UMLS CUI [4,2]
C0206054
UMLS CUI [4,3]
C0456904
UMLS CUI [5]
C0009450
UMLS CUI [6]
C0683322
UMLS CUI [7,1]
C2348563
UMLS CUI [7,2]
C0162340
UMLS CUI [7,3]
C1299582
UMLS CUI [8,1]
C1515089
UMLS CUI [8,2]
C0007194
UMLS CUI [9]
C2702800
UMLS CUI [10]
C0023671
UMLS CUI [11,1]
C1301624
UMLS CUI [11,2]
C0003281
UMLS CUI [12]
C2348568
UMLS CUI [13]
C0013230
UMLS CUI [14]
C2346570
UMLS CUI [15,1]
C0020676
UMLS CUI [15,2]
C0205318
UMLS CUI [16,1]
C0020550
UMLS CUI [16,2]
C0205318
UMLS CUI [17]
C0730561
UMLS CUI [18,1]
C0686904
UMLS CUI [18,2]
C1960973
UMLS CUI [19,1]
C0032961
UMLS CUI [19,2]
C0240802
UMLS CUI [20,1]
C3831118
UMLS CUI [20,2]
C0700589
UMLS CUI [20,3]
C0558080
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Similar models

Eligibility Atrial Fibrillation NCT00903370

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Release of information consent
Item
able to sign informed consent and release of medical information forms
boolean
C0021430 (UMLS CUI [1])
C3166272 (UMLS CUI [2])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Indication Mitral valve operation
Item
clinical indications for mitral valve surgery for the following:
boolean
C3146298 (UMLS CUI [1,1])
C0519382 (UMLS CUI [1,2])
Organic disease Mitral Valve
Item
1. organic mitral valve disease; or
boolean
C0683324 (UMLS CUI [1,1])
C0026264 (UMLS CUI [1,2])
Functional mitral regurgitation | Ischemia Excluded
Item
2. functional non-ischemic mitral regurgitation; or
boolean
C0340369 (UMLS CUI [1])
C0022116 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Ischaemic mitral regurgitation | Disease of mitral valve structural
Item
3. ischemic mitral regurgitation with evidence of concomitant structural mitral valve disease
boolean
C4087284 (UMLS CUI [1])
C0026265 (UMLS CUI [2,1])
C0678594 (UMLS CUI [2,2])
Patient need for Surgical Management Functional tricuspid regurgitation | Patient need for Surgical Management Patent Foramen Ovale | Coronary Artery Bypass Surgery | Aortic arch Interventional procedure | Aortic valve Interventional procedure | Sternotomy | Minimally Invasive Surgical Procedures
Item
note: may include need for surgical management of functional tricuspid regurgitation or patent foramen ovale. may also include concomitant cabg, aortic arch or aortic valve procedure. surgical intervention may be performed via sternotomy or minimally invasive procedure.
boolean
C0686904 (UMLS CUI [1,1])
C1515089 (UMLS CUI [1,2])
C0340392 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C1515089 (UMLS CUI [2,2])
C0016522 (UMLS CUI [2,3])
C0010055 (UMLS CUI [3])
C0003489 (UMLS CUI [4,1])
C0184661 (UMLS CUI [4,2])
C0003501 (UMLS CUI [5,1])
C0184661 (UMLS CUI [5,2])
C0185792 (UMLS CUI [6])
C0282624 (UMLS CUI [7])
Persistent atrial fibrillation Duration | Patient need for Pharmacological cardioversion | Patient need for Electric Countershock
Item
a) persistent 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 [1,1])
C0449238 (UMLS CUI [1,2])
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
Item
duration of af must be documented by medical history and
boolean
C0004238 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
Atrial Fibrillation Electrocardiography
Item
presence of af must be documented by a direct electrocardiographic assessment within 6 months prior to randomization.
boolean
C0004238 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
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
Item
duration of af must be documented by medical history and
boolean
C0004238 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
Atrial Fibrillation Electrocardiography
Item
presence of af must be documented by a direct electrocardiographic assessment upon arrival in the or.
boolean
C0004238 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
Monitor heart rate and rhythm
Item
able to use heart rhythm monitor
boolean
C0513462 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Atrial Fibrillation | Indication Absent Mitral valve operation | Paroxysmal atrial fibrillation | Thrombus of left atrium Transesophageal Echocardiography Intraoperative | Communicable Disease | Mental impairment | Study Protocol Comprehension Unable | Surgical Management Hypertrophic Cardiomyopathy | Catheter ablation for atrial fibrillation | Life Expectancy | Medical contraindication Anticoagulation Therapy | Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Hypothyroidism Uncontrolled | Hyperthyroidism Uncontrolled | Percent predicted FEV1 | Patient need for Home oxygen therapy | Pregnancy Pregnancy test positive | Childbearing Potential Contraceptive methods Unwilling
Item
1. af without indication for mitral valve surgery 2. af is paroxysmal 3. evidence of left atrial thrombus by intra-operative tee 4. evidence of active infection 5. mental impairment or other conditions that may not allow subject to understand the nature, significance, and scope of study 6. surgical management of hypertrophic obstructive cardiomyopathy 7. previous catheter ablation for af 8. life expectancy of less than one year 9. absolute contraindications for anticoagulation therapy 10. enrollment in concomitant drug or device trials 11. uncontrolled hypo- or hyperthyroidism 12. fev1 < 30% of predicted value and/or need for home oxygen therapy 13. women who are pregnant as evidenced by positive pregnancy test 14. women of childbearing age who do not agree to be on adequate birth control throughout the period of the trial.
boolean
C0004238 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0519382 (UMLS CUI [2,3])
C0235480 (UMLS CUI [3])
C3532827 (UMLS CUI [4,1])
C0206054 (UMLS CUI [4,2])
C0456904 (UMLS CUI [4,3])
C0009450 (UMLS CUI [5])
C0683322 (UMLS CUI [6])
C2348563 (UMLS CUI [7,1])
C0162340 (UMLS CUI [7,2])
C1299582 (UMLS CUI [7,3])
C1515089 (UMLS CUI [8,1])
C0007194 (UMLS CUI [8,2])
C2702800 (UMLS CUI [9])
C0023671 (UMLS CUI [10])
C1301624 (UMLS CUI [11,1])
C0003281 (UMLS CUI [11,2])
C2348568 (UMLS CUI [12])
C0013230 (UMLS CUI [13])
C2346570 (UMLS CUI [14])
C0020676 (UMLS CUI [15,1])
C0205318 (UMLS CUI [15,2])
C0020550 (UMLS CUI [16,1])
C0205318 (UMLS CUI [16,2])
C0730561 (UMLS CUI [17])
C0686904 (UMLS CUI [18,1])
C1960973 (UMLS CUI [18,2])
C0032961 (UMLS CUI [19,1])
C0240802 (UMLS CUI [19,2])
C3831118 (UMLS CUI [20,1])
C0700589 (UMLS CUI [20,2])
C0558080 (UMLS CUI [20,3])
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