ID

37448

Description

CONcomitant eValuation of Epicor Left atRial Therapy for AF; ODM derived from: https://clinicaltrials.gov/show/NCT00519194

Link

https://clinicaltrials.gov/show/NCT00519194

Keywords

Versions (1)
  1. 7/28/19 7/28/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 28, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00519194

English

Eligibility Atrial Fibrillation NCT00519194

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18-80 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
permanent af defined as continuous af lasting > one year or non self-terminating af lasting > seven days but no more than one year with at least one failed dc cardioversion
Description

Permanent atrial fibrillation Duration | Direct current cardioversion Quantity failed

Data type

boolean

Alias
UMLS CUI [1,1]
C2586056
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0542380
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
have a concomitant indication for open chest and/or open heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, patent foramen ovale (pfo) closure or coronary artery bypass surgery
Description

Indication Thoracic Surgical Procedure Open approach | Indication Open heart surgery | Mitral valvuloplasty | Replacement of mitral valve | Valvuloplasty of aortic valve | Replacement of aortic valve | Repair of tricuspid valve | Replacement of tricuspid valve | Closure of patent foramen ovale | Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0524832
UMLS CUI [1,3]
C0348025
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0189745
UMLS CUI [3]
C0396849
UMLS CUI [4]
C0026268
UMLS CUI [5]
C0396949
UMLS CUI [6]
C0003506
UMLS CUI [7]
C0396899
UMLS CUI [8]
C0190119
UMLS CUI [9]
C0189967
UMLS CUI [10]
C0010055
be able to take anticoagulation therapy
Description

Anticoagulation Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0003281
be able to fulfill study requirements
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
be able to sign study-specific informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of a previously implanted device in or adjacent to the treatment target area that may alter the delivery of therapy
Description

Implant Treatment Target Area | Implant Changing Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1521840
UMLS CUI [1,4]
C0205146
UMLS CUI [2,1]
C0021102
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0087111
prior cardiac surgery
Description

Cardiac Surgery Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C0205156
presence of active endocarditis, local or system infection
Description

Endocarditis | Local infection | Sepsis

Data type

boolean

Alias
UMLS CUI [1]
C0014118
UMLS CUI [2]
C1400591
UMLS CUI [3]
C0243026
presence of advanced heart failure (nyha class > ii, & lvef < 20%)
Description

Heart failure Advanced New York Heart Association Classification | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1275491
UMLS CUI [2]
C0428772
intraaortic balloon pump, iv inotropes or vasoactive agents within 30 days
Description

Intra-aortic balloon pump | Inotropic agent Intravenous | Vasoactive agent Intravenous

Data type

boolean

Alias
UMLS CUI [1]
C0702122
UMLS CUI [2,1]
C0304509
UMLS CUI [2,2]
C1522726
UMLS CUI [3,1]
C0597639
UMLS CUI [3,2]
C1522726
emergent cardiac surgery due to acute mi or acute mitral regurgitation
Description

Emergency Cardiac Surgery | Etiology Myocardial Infarction | Etiology Mitral Valve Insufficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C0013956
UMLS CUI [1,2]
C0018821
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0027051
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0026266
life expectancy < 1 year
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
major or progressive non-cardiac disease
Description

Disease Major | Progressive Disease | Exception Heart Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C1335499
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0018799
presence of left atrial thrombi
Description

Thrombus of left atrium

Data type

boolean

Alias
UMLS CUI [1]
C3532827
left atrial diameter > 6.0 cm
Description

Left atrial Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C1301886
any condition that prevents investigator from safely performing procedure
Description

Condition Preventing Interventional procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0184661
positive urine or serum pregnancy test
Description

Urine pregnancy test positive | Serum pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1]
C0430059
UMLS CUI [2]
C0430063
prior left atrial ablation
Description

Left atrial Ablation

Data type

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0547070
currently participating in another clinical research study
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Atrial Fibrillation NCT00519194

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18-80 years old
boolean
C0001779 (UMLS CUI [1])
Permanent atrial fibrillation Duration | Direct current cardioversion Quantity failed
Item
permanent af defined as continuous af lasting > one year or non self-terminating af lasting > seven days but no more than one year with at least one failed dc cardioversion
boolean
C2586056 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0542380 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Indication Thoracic Surgical Procedure Open approach | Indication Open heart surgery | Mitral valvuloplasty | Replacement of mitral valve | Valvuloplasty of aortic valve | Replacement of aortic valve | Repair of tricuspid valve | Replacement of tricuspid valve | Closure of patent foramen ovale | Coronary Artery Bypass Surgery
Item
have a concomitant indication for open chest and/or open heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, patent foramen ovale (pfo) closure or coronary artery bypass surgery
boolean
C3146298 (UMLS CUI [1,1])
C0524832 (UMLS CUI [1,2])
C0348025 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C0189745 (UMLS CUI [2,2])
C0396849 (UMLS CUI [3])
C0026268 (UMLS CUI [4])
C0396949 (UMLS CUI [5])
C0003506 (UMLS CUI [6])
C0396899 (UMLS CUI [7])
C0190119 (UMLS CUI [8])
C0189967 (UMLS CUI [9])
C0010055 (UMLS CUI [10])
Anticoagulation Therapy
Item
be able to take anticoagulation therapy
boolean
C0003281 (UMLS CUI [1])
Protocol Compliance
Item
be able to fulfill study requirements
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
be able to sign study-specific informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Implant Treatment Target Area | Implant Changing Therapy
Item
presence of a previously implanted device in or adjacent to the treatment target area that may alter the delivery of therapy
boolean
C0021102 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0205146 (UMLS CUI [1,4])
C0021102 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Cardiac Surgery Previous
Item
prior cardiac surgery
boolean
C0018821 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Endocarditis | Local infection | Sepsis
Item
presence of active endocarditis, local or system infection
boolean
C0014118 (UMLS CUI [1])
C1400591 (UMLS CUI [2])
C0243026 (UMLS CUI [3])
Heart failure Advanced New York Heart Association Classification | Left ventricular ejection fraction
Item
presence of advanced heart failure (nyha class > ii, & lvef < 20%)
boolean
C0018801 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0428772 (UMLS CUI [2])
Intra-aortic balloon pump | Inotropic agent Intravenous | Vasoactive agent Intravenous
Item
intraaortic balloon pump, iv inotropes or vasoactive agents within 30 days
boolean
C0702122 (UMLS CUI [1])
C0304509 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C0597639 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
Emergency Cardiac Surgery | Etiology Myocardial Infarction | Etiology Mitral Valve Insufficiency
Item
emergent cardiac surgery due to acute mi or acute mitral regurgitation
boolean
C0013956 (UMLS CUI [1,1])
C0018821 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0027051 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0026266 (UMLS CUI [3,2])
Life Expectancy
Item
life expectancy < 1 year
boolean
C0023671 (UMLS CUI [1])
Disease Major | Progressive Disease | Exception Heart Diseases
Item
major or progressive non-cardiac disease
boolean
C0012634 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1335499 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0018799 (UMLS CUI [3,2])
Thrombus of left atrium
Item
presence of left atrial thrombi
boolean
C3532827 (UMLS CUI [1])
Left atrial Diameter
Item
left atrial diameter > 6.0 cm
boolean
C0225860 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Condition Preventing Interventional procedure
Item
any condition that prevents investigator from safely performing procedure
boolean
C0348080 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
Urine pregnancy test positive | Serum pregnancy test positive
Item
positive urine or serum pregnancy test
boolean
C0430059 (UMLS CUI [1])
C0430063 (UMLS CUI [2])
Left atrial Ablation
Item
prior left atrial ablation
boolean
C0225860 (UMLS CUI [1,1])
C0547070 (UMLS CUI [1,2])
Study Subject Participation Status
Item
currently participating in another clinical research study
boolean
C2348568 (UMLS CUI [1])
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