ID

37590

Description

Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT01873352

Link

https://clinicaltrials.gov/show/NCT01873352

Keywords

Versions (1)
  1. 8/9/19 8/9/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 9, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01873352

English

Eligibility Atrial Fibrillation NCT01873352

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
history of paf and plans for a guideline-supported catheter ablation procedure. paroxysmal af is defined as af with duration of 30 secs to 7 days.
Description

Paroxysmal atrial fibrillation Duration | Catheter ablation Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0235480
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0162563
UMLS CUI [2,2]
C1301732
history of significant hypertension (defined as sbp ≥130 mm hg and/or dbp ≥80 mmhg) and receiving treatment with at least one anti-hypertensive medication
Description

Hypertensive disease | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C0003364
UMLS CUI [4,2]
C1265611
renal vasculature accessible as determined by pre-procedural renal mra
Description

Vasculature renal Access Possible | Magnetic Resonance Angiography renal preprocedural

Data type

boolean

Alias
UMLS CUI [1,1]
C3714653
UMLS CUI [1,2]
C0022646
UMLS CUI [1,3]
C0444454
UMLS CUI [1,4]
C0332149
UMLS CUI [2,1]
C0243032
UMLS CUI [2,2]
C0022646
UMLS CUI [2,3]
C0585032
willingness to comply with all post-procedural follow-up requirements and to sign informed consent
Description

Compliance Follow-up | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C3274571
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability to undergo af catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
Description

Catheter ablation Receive Unable | Thrombus of left atrium | Medical contraindication Anticoagulation Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0162563
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C3532827
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0003281
prior left atrial ablation for an atrial arrhythmia
Description

Left atrium Ablation Atrial arrhythmia

Data type

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0547070
UMLS CUI [1,3]
C0085611
nyha class iv congestive heart failure
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
pers or longstanding pers af (duration > 7 days)
Description

Persistent atrial fibrillation | Longstanding persistent atrial fibrillation Duration

Data type

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2,1]
C3873617
UMLS CUI [2,2]
C0449238
renal artery anatomy that is ineligible for treatment
Description

Renal artery Anatomy Ineligible Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C0700276
UMLS CUI [1,3]
C1512714
UMLS CUI [1,4]
C0087111
an estimated glomerular filtration rate (egfr) < 45ml/min/1.73m2, using the mdrd calculation
Description

GFR estimation by MDRD

Data type

boolean

Alias
UMLS CUI [1]
C2170215
life expectancy <1 year for any medical condition
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Atrial Fibrillation NCT01873352

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Paroxysmal atrial fibrillation Duration | Catheter ablation Planned
Item
history of paf and plans for a guideline-supported catheter ablation procedure. paroxysmal af is defined as af with duration of 30 secs to 7 days.
boolean
C0235480 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0162563 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Hypertensive disease | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents Quantity
Item
history of significant hypertension (defined as sbp ≥130 mm hg and/or dbp ≥80 mmhg) and receiving treatment with at least one anti-hypertensive medication
boolean
C0020538 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0003364 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Vasculature renal Access Possible | Magnetic Resonance Angiography renal preprocedural
Item
renal vasculature accessible as determined by pre-procedural renal mra
boolean
C3714653 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
C0444454 (UMLS CUI [1,3])
C0332149 (UMLS CUI [1,4])
C0243032 (UMLS CUI [2,1])
C0022646 (UMLS CUI [2,2])
C0585032 (UMLS CUI [2,3])
Compliance Follow-up | Informed Consent
Item
willingness to comply with all post-procedural follow-up requirements and to sign informed consent
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Catheter ablation Receive Unable | Thrombus of left atrium | Medical contraindication Anticoagulation Therapy
Item
inability to undergo af catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
boolean
C0162563 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3532827 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0003281 (UMLS CUI [3,2])
Left atrium Ablation Atrial arrhythmia
Item
prior left atrial ablation for an atrial arrhythmia
boolean
C0225860 (UMLS CUI [1,1])
C0547070 (UMLS CUI [1,2])
C0085611 (UMLS CUI [1,3])
Congestive heart failure New York Heart Association Classification
Item
nyha class iv congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Persistent atrial fibrillation | Longstanding persistent atrial fibrillation Duration
Item
pers or longstanding pers af (duration > 7 days)
boolean
C2585653 (UMLS CUI [1])
C3873617 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Renal artery Anatomy Ineligible Therapeutic procedure
Item
renal artery anatomy that is ineligible for treatment
boolean
C0035065 (UMLS CUI [1,1])
C0700276 (UMLS CUI [1,2])
C1512714 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
GFR estimation by MDRD
Item
an estimated glomerular filtration rate (egfr) < 45ml/min/1.73m2, using the mdrd calculation
boolean
C2170215 (UMLS CUI [1])
Life Expectancy
Item
life expectancy <1 year for any medical condition
boolean
C0023671 (UMLS CUI [1])
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