ID

25774

Beschreibung

Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study; ODM derived from: https://clinicaltrials.gov/show/NCT00431834

Link

https://clinicaltrials.gov/show/NCT00431834

Stichworte

Versionen (1)
  1. 19.09.17 19.09.17 -
Hochgeladen am

19. September 2017

DOI

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Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00431834

Englisch

Eligibility Atrial Fibrillation NCT00431834

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have a documented history of permanent af (cardioversion failure) as defined by the acc/aha/esc guidelines.
Beschreibung

Permanent atrial fibrillation | Atrial cardioversion failed

Datentyp

boolean

Alias
UMLS CUI [1]
C2586056
UMLS CUI [2,1]
C0199550
UMLS CUI [2,2]
C0231175
2. concomitant indication (other than af) for open-heart surgery for one or more of the following:
Beschreibung

Indication Open heart surgery | Exception Atrial Fibrillation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0189745
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004238
mitral valve repair or replacement
Beschreibung

Mitral valvuloplasty | Replacement of mitral valve

Datentyp

boolean

Alias
UMLS CUI [1]
C0396849
UMLS CUI [2]
C0026268
aortic valve repair or replacement
Beschreibung

Valvuloplasty of aortic valve | Replacement of aortic valve

Datentyp

boolean

Alias
UMLS CUI [1]
C0396949
UMLS CUI [2]
C0003506
tricuspid valve repair or replacement
Beschreibung

Repair of tricuspid valve | Replacement of tricuspid valve

Datentyp

boolean

Alias
UMLS CUI [1]
C0396899
UMLS CUI [2]
C0190119
atrial septal defect (asd) repair
Beschreibung

Atrioseptoplasty

Datentyp

boolean

Alias
UMLS CUI [1]
C0189965
patent foramen ovale (pfo) closure
Beschreibung

Closure of patent foramen ovale

Datentyp

boolean

Alias
UMLS CUI [1]
C0189967
coronary artery bypass procedures
Beschreibung

Coronary Artery Bypass Surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0010055
3. greater than or equal to 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. able and willing to comply with study requirements by signing a consent form
Beschreibung

Protocol Compliance | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
5. must be able to take the anticoagulant warfarin (coumadin)
Beschreibung

Able to take Warfarin | Able to take Coumadin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4075001
UMLS CUI [1,2]
C0043031
UMLS CUI [2,1]
C4075001
UMLS CUI [2,2]
C0699129
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. wolff-parkinson-white syndrome
Beschreibung

Wolff-Parkinson-White Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0043202
2. nyha class = iv
Beschreibung

New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C1275491
3. left ventricular ejection fraction ≤ 30%
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
4. need for emergent cardiac surgery (i.e. cardiogenic shock)
Beschreibung

Cardiac Surgery Emergency Patient need for | Shock, Cardiogenic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C0013956
UMLS CUI [1,3]
C0686904
UMLS CUI [2]
C0036980
5. previous ablation for atrial fibrillation, av-nodal ablation, or surgical maze procedure
Beschreibung

Ablation for atrial fibrillation | Ablation of Cardiac Atrioventricular Node | Surgical Maze Procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C2702800
UMLS CUI [2]
C3275044
UMLS CUI [3]
C3272262
6. contraindication for anticoagulation therapy
Beschreibung

Medical contraindication Anticoagulation Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003281
7. left atrial diameter > 7.0 cm
Beschreibung

Left atrial structure Diameter size

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0456389
8. preoperative need for an intra-aortic balloon pump or intravenous inotropes
Beschreibung

Intra-aortic balloon pump Preoperative Patient need for | Inotropic agent Intravenous Preoperative Patient need for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0702122
UMLS CUI [1,2]
C0445204
UMLS CUI [1,3]
C0686904
UMLS CUI [2,1]
C0304509
UMLS CUI [2,2]
C1522726
UMLS CUI [2,3]
C0445204
UMLS CUI [2,4]
C0686904
9. renal failure requiring dialysis or hepatic failure
Beschreibung

Kidney Failure Requirement Dialysis | Liver Failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0011946
UMLS CUI [2]
C0085605
10. life expectancy of less than one year
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
11. pregnancy or desire to be pregnant within 12 months of the study treatment.
Beschreibung

Pregnancy | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
12. current diagnosis of active systemic infection
Beschreibung

Sepsis

Datentyp

boolean

Alias
UMLS CUI [1]
C0243026
13. documented mi 6 weeks prior to study enrollment
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
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Ähnliche Modelle

Eligibility Atrial Fibrillation NCT00431834

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Permanent atrial fibrillation | Atrial cardioversion failed
Item
1. patients must have a documented history of permanent af (cardioversion failure) as defined by the acc/aha/esc guidelines.
boolean
C2586056 (UMLS CUI [1])
C0199550 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Indication Open heart surgery | Exception Atrial Fibrillation
Item
2. concomitant indication (other than af) for open-heart surgery for one or more of the following:
boolean
C3146298 (UMLS CUI [1,1])
C0189745 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
Mitral valvuloplasty | Replacement of mitral valve
Item
mitral valve repair or replacement
boolean
C0396849 (UMLS CUI [1])
C0026268 (UMLS CUI [2])
Valvuloplasty of aortic valve | Replacement of aortic valve
Item
aortic valve repair or replacement
boolean
C0396949 (UMLS CUI [1])
C0003506 (UMLS CUI [2])
Repair of tricuspid valve | Replacement of tricuspid valve
Item
tricuspid valve repair or replacement
boolean
C0396899 (UMLS CUI [1])
C0190119 (UMLS CUI [2])
Atrioseptoplasty
Item
atrial septal defect (asd) repair
boolean
C0189965 (UMLS CUI [1])
Closure of patent foramen ovale
Item
patent foramen ovale (pfo) closure
boolean
C0189967 (UMLS CUI [1])
Coronary Artery Bypass Surgery
Item
coronary artery bypass procedures
boolean
C0010055 (UMLS CUI [1])
Age
Item
3. greater than or equal to 18 years of age
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance | Informed Consent
Item
4. able and willing to comply with study requirements by signing a consent form
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Able to take Warfarin | Able to take Coumadin
Item
5. must be able to take the anticoagulant warfarin (coumadin)
boolean
C4075001 (UMLS CUI [1,1])
C0043031 (UMLS CUI [1,2])
C4075001 (UMLS CUI [2,1])
C0699129 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Wolff-Parkinson-White Syndrome
Item
1. wolff-parkinson-white syndrome
boolean
C0043202 (UMLS CUI [1])
New York Heart Association Classification
Item
2. nyha class = iv
boolean
C1275491 (UMLS CUI [1])
Left ventricular ejection fraction
Item
3. left ventricular ejection fraction ≤ 30%
boolean
C0428772 (UMLS CUI [1])
Cardiac Surgery Emergency Patient need for | Shock, Cardiogenic
Item
4. need for emergent cardiac surgery (i.e. cardiogenic shock)
boolean
C0018821 (UMLS CUI [1,1])
C0013956 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0036980 (UMLS CUI [2])
Ablation for atrial fibrillation | Ablation of Cardiac Atrioventricular Node | Surgical Maze Procedure
Item
5. previous ablation for atrial fibrillation, av-nodal ablation, or surgical maze procedure
boolean
C2702800 (UMLS CUI [1])
C3275044 (UMLS CUI [2])
C3272262 (UMLS CUI [3])
Medical contraindication Anticoagulation Therapy
Item
6. contraindication for anticoagulation therapy
boolean
C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
Left atrial structure Diameter size
Item
7. left atrial diameter > 7.0 cm
boolean
C0225860 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
Intra-aortic balloon pump Preoperative Patient need for | Inotropic agent Intravenous Preoperative Patient need for
Item
8. preoperative need for an intra-aortic balloon pump or intravenous inotropes
boolean
C0702122 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0304509 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C0445204 (UMLS CUI [2,3])
C0686904 (UMLS CUI [2,4])
Kidney Failure Requirement Dialysis | Liver Failure
Item
9. renal failure requiring dialysis or hepatic failure
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
C0085605 (UMLS CUI [2])
Life Expectancy
Item
10. life expectancy of less than one year
boolean
C0023671 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
11. pregnancy or desire to be pregnant within 12 months of the study treatment.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Sepsis
Item
12. current diagnosis of active systemic infection
boolean
C0243026 (UMLS CUI [1])
Myocardial Infarction
Item
13. documented mi 6 weeks prior to study enrollment
boolean
C0027051 (UMLS CUI [1])
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