ID

25774

Description

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

Keywords

Versions (1)
  1. 9/19/17 9/19/17 -
Uploaded on

September 19, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Atrial Fibrillation NCT00431834

English

Eligibility Atrial Fibrillation NCT00431834

1 forms  
Inclusion Criteria
Description

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.
Description

Permanent atrial fibrillation | Atrial cardioversion failed

Data type

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:
Description

Indication Open heart surgery | Exception Atrial Fibrillation

Data type

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
Description

Mitral valvuloplasty | Replacement of mitral valve

Data type

boolean

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

Valvuloplasty of aortic valve | Replacement of aortic valve

Data type

boolean

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

Repair of tricuspid valve | Replacement of tricuspid valve

Data type

boolean

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

Atrioseptoplasty

Data type

boolean

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

Closure of patent foramen ovale

Data type

boolean

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

Coronary Artery Bypass Surgery

Data type

boolean

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

Age

Data type

boolean

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

Protocol Compliance | Informed Consent

Data type

boolean

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

Able to take Warfarin | Able to take Coumadin

Data type

boolean

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

Exclusion Criteria

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

Wolff-Parkinson-White Syndrome

Data type

boolean

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

New York Heart Association Classification

Data type

boolean

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

Left ventricular ejection fraction

Data type

boolean

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

Cardiac Surgery Emergency Patient need for | Shock, Cardiogenic

Data type

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
Description

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

Data type

boolean

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

Medical contraindication Anticoagulation Therapy

Data type

boolean

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

Left atrial structure Diameter size

Data type

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
Description

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

Data type

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
Description

Kidney Failure Requirement Dialysis | Liver Failure

Data type

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
Description

Life Expectancy

Data type

boolean

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

Pregnancy | Pregnancy, Planned

Data type

boolean

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

Sepsis

Data type

boolean

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

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
Back to the top of the page

Similar models

Eligibility Atrial Fibrillation NCT00431834

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial