ID

23467

Beschrijving

Medtronic Concomitant Utilization of Radio Frequency for Atrial Fibrillation CURE-AF/Persistent; ODM derived from: https://clinicaltrials.gov/show/NCT00506493

Link

https://clinicaltrials.gov/show/NCT00506493

Trefwoorden

Versies (1)
  1. 06-07-17 06-07-17 -
Geüploaded op

6 juli 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00506493

Engels

Eligibility Atrial Fibrillation NCT00506493

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have a documented history of persistent af as defined by the acc/aha/esc guidelines: characterized as episodes of non-self-terminating atrial fibrillation that usually lasts more than 7 days.
Beschrijving

Persistent atrial fibrillation | Atrial Fibrillation Episode Duration

Datatype

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C0449238
2. concomitant indication (other than af) for open-heart surgery for one or more of the following:
Beschrijving

Indication for Open heart surgery

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0189745
mitral valve repair or replacement
Beschrijving

Mitral Valve: Repair | Replacement of mitral valve

Datatype

boolean

Alias
UMLS CUI [1]
C0869755
UMLS CUI [2]
C0026268
aortic valve repair or replacement
Beschrijving

Aortic Valve: Repair | Replacement of aortic valve

Datatype

boolean

Alias
UMLS CUI [1]
C0869750
UMLS CUI [2]
C0003506
tricuspid valve repair or replacement
Beschrijving

Repair of tricuspid valve | Replacement of tricuspid valve

Datatype

boolean

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

Atrioseptoplasty

Datatype

boolean

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

Closure of patent foramen ovale

Datatype

boolean

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

Coronary Artery Bypass Surgery

Datatype

boolean

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

Age

Datatype

boolean

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

Protocol Compliance | Informed Consent

Datatype

boolean

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

Able to take Anticoagulant | Warfarin | Coumadin

Datatype

boolean

Alias
UMLS CUI [1,1]
C4075001
UMLS CUI [1,2]
C0003280
UMLS CUI [2]
C0043031
UMLS CUI [3]
C0699129
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Wolff-Parkinson-White Syndrome

Datatype

boolean

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

New York Heart Association Classification

Datatype

boolean

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

Left ventricular ejection fraction

Datatype

boolean

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

Cardiac Surgery Emergency Patient need for | Shock, Cardiogenic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C0184893
UMLS CUI [1,3]
C0686904
UMLS CUI [2]
C0036980
5. previous atrial ablation for af, av-nodal ablation, or surgical maze procedure
Beschrijving

Ablation for atrial fibrillation | Ablation of Cardiac Atrioventricular Node | Maze procedure

Datatype

boolean

Alias
UMLS CUI [1]
C2702800
UMLS CUI [2]
C3275044
UMLS CUI [3]
C0397414
6. contraindication for anticoagulation therapy
Beschrijving

Medical contraindication Anticoagulation

Datatype

boolean

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

Left atrium Diameter Size

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Kidney Failure Requirement Dialysis | Liver Failure

Datatype

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
Beschrijving

Life Expectancy

Datatype

boolean

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

Pregnancy | Pregnancy, Planned

Datatype

boolean

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

Sepsis

Datatype

boolean

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

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
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Similar models

Eligibility Atrial Fibrillation NCT00506493

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Persistent atrial fibrillation | Atrial Fibrillation Episode Duration
Item
1. patients must have a documented history of persistent af as defined by the acc/aha/esc guidelines: characterized as episodes of non-self-terminating atrial fibrillation that usually lasts more than 7 days.
boolean
C2585653 (UMLS CUI [1])
C0004238 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Indication for Open heart surgery
Item
2. concomitant indication (other than af) for open-heart surgery for one or more of the following:
boolean
C0392360 (UMLS CUI [1,1])
C0189745 (UMLS CUI [1,2])
Mitral Valve: Repair | Replacement of mitral valve
Item
mitral valve repair or replacement
boolean
C0869755 (UMLS CUI [1])
C0026268 (UMLS CUI [2])
Aortic Valve: Repair | Replacement of aortic valve
Item
aortic valve repair or replacement
boolean
C0869750 (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 Anticoagulant | Warfarin | Coumadin
Item
5. must be able to take the anticoagulant warfarin (coumadin)
boolean
C4075001 (UMLS CUI [1,1])
C0003280 (UMLS CUI [1,2])
C0043031 (UMLS CUI [2])
C0699129 (UMLS CUI [3])
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])
C0184893 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0036980 (UMLS CUI [2])
Ablation for atrial fibrillation | Ablation of Cardiac Atrioventricular Node | Maze procedure
Item
5. previous atrial ablation for af, av-nodal ablation, or surgical maze procedure
boolean
C2702800 (UMLS CUI [1])
C3275044 (UMLS CUI [2])
C0397414 (UMLS CUI [3])
Medical contraindication Anticoagulation
Item
6. contraindication for anticoagulation therapy
boolean
C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
Left atrium 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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