ID

34787

Description

SORT - AF Supervised Obesity Reduction Trial for AF Ablation Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02064114

Link

https://clinicaltrials.gov/show/NCT02064114

Keywords

  1. 1/29/19 1/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 29, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Atrial Fibrillation NCT02064114

Eligibility Atrial Fibrillation NCT02064114

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
overweight with a bmi ≥ 30
Description

Overweight | Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C0497406
UMLS CUI [2]
C1305855
obtained written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
symptomatic atrial fibrillation with indication for ablation
Description

ATRIAL FIBRILLATION SYMPTOMATIC | Indication Ablation

Data type

boolean

Alias
UMLS CUI [1]
C0741283
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0547070
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
age <18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
permanent atrial fibrillation (failed cardioversion or episode duration > 12 months)
Description

Permanent atrial fibrillation | Cardioversion failed | Episode Duration

Data type

boolean

Alias
UMLS CUI [1]
C2586056
UMLS CUI [2,1]
C0199550
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C0332189
UMLS CUI [3,2]
C0449238
previous surgical or interventional therapy of atrial fibrillation
Description

Operative Surgical Procedures Previous Atrial Fibrillation | Interventional procedure Previous Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0004238
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0004238
bmi > 40
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment
Description

Pregnancy | Childbearing Potential Pregnancy test negative Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0427780
UMLS CUI [2,3]
C0332197
history of hemorrhagic diathesis or other coagulopathies
Description

Bleeding tendency | Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
contraindications for oral anticoagulation
Description

Medical contraindication Anticoagulation Therapy Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003281
UMLS CUI [1,3]
C1527415
hyper- or hypothyroidism
Description

Hyperthyroidism | Hypothyroidism

Data type

boolean

Alias
UMLS CUI [1]
C0020550
UMLS CUI [2]
C0020676
drug or chronic alcohol abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
has any condition that would make participation not be in the best interest of the subject
Description

Condition Study Subject Participation Status Unfavorable

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C3640815
incompliants
Description

Compliance behavior Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332268
unable to perform athletic exercise due to disease or disability
Description

Exercise Athletic Unable | Etiology Disease | Etiology Disability

Data type

boolean

Alias
UMLS CUI [1,1]
C0015259
UMLS CUI [1,2]
C1510656
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0012634
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0231170
resident outside hamburg
Description

Resident Remote

Data type

boolean

Alias
UMLS CUI [1,1]
C2347958
UMLS CUI [1,2]
C0205157

Similar models

Eligibility Atrial Fibrillation NCT02064114

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Overweight | Body mass index
Item
overweight with a bmi ≥ 30
boolean
C0497406 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Informed Consent
Item
obtained written informed consent
boolean
C0021430 (UMLS CUI [1])
ATRIAL FIBRILLATION SYMPTOMATIC | Indication Ablation
Item
symptomatic atrial fibrillation with indication for ablation
boolean
C0741283 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0547070 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
age <18 years
boolean
C0001779 (UMLS CUI [1])
Permanent atrial fibrillation | Cardioversion failed | Episode Duration
Item
permanent atrial fibrillation (failed cardioversion or episode duration > 12 months)
boolean
C2586056 (UMLS CUI [1])
C0199550 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0332189 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
Operative Surgical Procedures Previous Atrial Fibrillation | Interventional procedure Previous Atrial Fibrillation
Item
previous surgical or interventional therapy of atrial fibrillation
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
C0184661 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0004238 (UMLS CUI [2,3])
Body mass index
Item
bmi > 40
boolean
C1305855 (UMLS CUI [1])
Pregnancy | Childbearing Potential Pregnancy test negative Absent
Item
pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Bleeding tendency | Blood Coagulation Disorders
Item
history of hemorrhagic diathesis or other coagulopathies
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
Medical contraindication Anticoagulation Therapy Oral
Item
contraindications for oral anticoagulation
boolean
C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,3])
Hyperthyroidism | Hypothyroidism
Item
hyper- or hypothyroidism
boolean
C0020550 (UMLS CUI [1])
C0020676 (UMLS CUI [2])
Substance Use Disorders
Item
drug or chronic alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Condition Study Subject Participation Status Unfavorable
Item
has any condition that would make participation not be in the best interest of the subject
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
Compliance behavior Lacking
Item
incompliants
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Exercise Athletic Unable | Etiology Disease | Etiology Disability
Item
unable to perform athletic exercise due to disease or disability
boolean
C0015259 (UMLS CUI [1,1])
C1510656 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0231170 (UMLS CUI [3,2])
Resident Remote
Item
resident outside hamburg
boolean
C2347958 (UMLS CUI [1,1])
C0205157 (UMLS CUI [1,2])

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