ID

37596

Beschrijving

Comparison of Redo PVI With vs. Without Renal Denervation for Recurrent AF After Initial PVI; ODM derived from: https://clinicaltrials.gov/show/NCT01959997

Link

https://clinicaltrials.gov/show/NCT01959997

Trefwoorden

Versies (1)
  1. 10-08-19 10-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01959997

Engels

Eligibility Atrial Fibrillation NCT01959997

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
prior pvi ablation procedure for paroxysmal af within past 2 years
Beschrijving

Pulmonary vein isolation Ablation Paroxysmal atrial fibrillation

Datatype

boolean

Alias
UMLS CUI [1,1]
C3544330
UMLS CUI [1,2]
C0547070
UMLS CUI [1,3]
C0235480
recurrent symptomatic paroxysmal af despite prior pvi
Beschrijving

Paroxysmal atrial fibrillation Symptomatic Recurrent | Pulmonary vein isolation Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0235480
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C2945760
UMLS CUI [2,1]
C3544330
UMLS CUI [2,2]
C0205156
history of essential hypertension requiring at least 2 chronic antihypertensive medications
Beschrijving

Essential Hypertension | Requirement Antihypertensive Agents Quantity chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0085580
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0003364
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0205191
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
persistent af after prior ablation
Beschrijving

Persistent atrial fibrillation | Status post Ablation

Datatype

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0547070
congestive heart failure (nyha iii-iv functional class)
Beschrijving

Congestive heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
left ventricle ejection fraction < 35%
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
left atrial diameter >55 mm
Beschrijving

Left atrium Diameter

Datatype

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C1301886
an estimated glomerular filtration rate (egfr) < 45ml/min/1.73m2, using the mdrd calculation
Beschrijving

GFR estimation by MDRD

Datatype

boolean

Alias
UMLS CUI [1]
C2170215
renal arteries unsuitable for rdn:
Beschrijving

Renal arteries Inappropriate Renal artery denervation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C3544270
1. inability to access renal vasculature
Beschrijving

Access Kidney Vasculature Unsuccessful

Datatype

boolean

Alias
UMLS CUI [1,1]
C0444454
UMLS CUI [1,2]
C0022646
UMLS CUI [1,3]
C3714653
UMLS CUI [1,4]
C1272705
2. main renal arteries < 4 mm in diameter or < 20 mm in length.
Beschrijving

Renal arteries Main Diameter | Renal arteries Main Length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C1542147
UMLS CUI [1,3]
C1301886
UMLS CUI [2,1]
C0035065
UMLS CUI [2,2]
C1542147
UMLS CUI [2,3]
C1444754
3. hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery
Beschrijving

Renal artery Haemodynamic test abnormal | Abnormal renal artery Anatomy | Renal Artery Stenosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C1112665
UMLS CUI [2,1]
C4024624
UMLS CUI [2,2]
C0700276
UMLS CUI [3]
C0035067
4. a history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment
Beschrijving

Renal artery Intervention | Angioplasty, Balloon | Stenting | Intervention Excludes Ablation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C0184661
UMLS CUI [2]
C0002996
UMLS CUI [3]
C2348535
UMLS CUI [4,1]
C0184661
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0547070
5. multiple main renal arteries to either kidney
Beschrijving

Renal arteries Main Multiple | Kidney Either

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C1542147
UMLS CUI [1,3]
C0439064
UMLS CUI [2,1]
C0022646
UMLS CUI [2,2]
C3844638
unwillingness to participate
Beschrijving

Study Subject Participation Status Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0558080
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Similar models

Eligibility Atrial Fibrillation NCT01959997

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Pulmonary vein isolation Ablation Paroxysmal atrial fibrillation
Item
prior pvi ablation procedure for paroxysmal af within past 2 years
boolean
C3544330 (UMLS CUI [1,1])
C0547070 (UMLS CUI [1,2])
C0235480 (UMLS CUI [1,3])
Paroxysmal atrial fibrillation Symptomatic Recurrent | Pulmonary vein isolation Previous
Item
recurrent symptomatic paroxysmal af despite prior pvi
boolean
C0235480 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C2945760 (UMLS CUI [1,3])
C3544330 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Essential Hypertension | Requirement Antihypertensive Agents Quantity chronic
Item
history of essential hypertension requiring at least 2 chronic antihypertensive medications
boolean
C0085580 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0003364 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0205191 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Persistent atrial fibrillation | Status post Ablation
Item
persistent af after prior ablation
boolean
C2585653 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0547070 (UMLS CUI [2,2])
Congestive heart failure New York Heart Association Classification
Item
congestive heart failure (nyha iii-iv functional class)
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
left ventricle ejection fraction < 35%
boolean
C0428772 (UMLS CUI [1])
Left atrium Diameter
Item
left atrial diameter >55 mm
boolean
C0225860 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
GFR estimation by MDRD
Item
an estimated glomerular filtration rate (egfr) < 45ml/min/1.73m2, using the mdrd calculation
boolean
C2170215 (UMLS CUI [1])
Renal arteries Inappropriate Renal artery denervation
Item
renal arteries unsuitable for rdn:
boolean
C0035065 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C3544270 (UMLS CUI [1,3])
Access Kidney Vasculature Unsuccessful
Item
1. inability to access renal vasculature
boolean
C0444454 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
C3714653 (UMLS CUI [1,3])
C1272705 (UMLS CUI [1,4])
Renal arteries Main Diameter | Renal arteries Main Length
Item
2. main renal arteries < 4 mm in diameter or < 20 mm in length.
boolean
C0035065 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0035065 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C1444754 (UMLS CUI [2,3])
Renal artery Haemodynamic test abnormal | Abnormal renal artery Anatomy | Renal Artery Stenosis
Item
3. hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery
boolean
C0035065 (UMLS CUI [1,1])
C1112665 (UMLS CUI [1,2])
C4024624 (UMLS CUI [2,1])
C0700276 (UMLS CUI [2,2])
C0035067 (UMLS CUI [3])
Renal artery Intervention | Angioplasty, Balloon | Stenting | Intervention Excludes Ablation
Item
4. a history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment
boolean
C0035065 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C0002996 (UMLS CUI [2])
C2348535 (UMLS CUI [3])
C0184661 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0547070 (UMLS CUI [4,3])
Renal arteries Main Multiple | Kidney Either
Item
5. multiple main renal arteries to either kidney
boolean
C0035065 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
C0022646 (UMLS CUI [2,1])
C3844638 (UMLS CUI [2,2])
Study Subject Participation Status Unwilling
Item
unwillingness to participate
boolean
C2348568 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
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