ID

34853

Description

Non-invasive Characterization of the Mechanisms of Atrial Fibrillation Maintenance; ODM derived from: https://clinicaltrials.gov/show/NCT02497248

Link

https://clinicaltrials.gov/show/NCT02497248

Keywords

Versions (1)
  1. 1/31/19 1/31/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 31, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02497248

English

Eligibility Atrial Fibrillation NCT02497248

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with paroxysmal af symptomatic and refractory to at least one antiarrhythmic medication.
Description

Paroxysmal atrial fibrillation Symptomatic | Anti-Arrhythmia Agents Quantity Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0235480
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0003195
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0205269
patients with persistent af symptomatic and refractory to at least one antiarrhythmic medication.
Description

Persistent atrial fibrillation Symptomatic | Anti-Arrhythmia Agents Quantity Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C2585653
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0003195
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0205269
patients with severe mitral stenosis (mitral valve area ≤1.5 cm2, stage d) and favorable valve morphology in the absence of left atrial thrombus or moderate-to-severe mitral regurgitation.
Description

Mitral Stenosis Severe Stage | Mitral valve area | Thrombus of left atrium Absent | Moderate to severe mitral regurgitation Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0026269
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1306673
UMLS CUI [2]
C0428818
UMLS CUI [3,1]
C3532827
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C4478243
UMLS CUI [4,2]
C0332197
patients must be able and willing to provide written informed consent to participate in the study.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
prior anticoagulation for> 4 weeks or transesophageal echocardiogram excluding intracardiac thrombi (in patients with paroxysmal af).
Description

Anticoagulation Therapy | Transesophageal Echocardiography Excludes Intracardiac thrombus

Data type

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2,1]
C0206054
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0876998
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with inadequate anticoagulation levels.
Description

Anticoagulation drug level Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C1168142
UMLS CUI [1,2]
C0205412
patients with left atrial thrombus, tumor, or another abnormality which precludes catheter introduction on tee prior to the procedure.
Description

Thrombus of left atrium Excludes Catheterization | Neoplasm Excludes Catheterization | Abnormality Excludes Catheterization

Data type

boolean

Alias
UMLS CUI [1,1]
C3532827
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0007430
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0007430
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0007430
patients with moderate-to-severe mitral regurgitation.
Description

Mitral valve regurgitation, moderate to severe

Data type

boolean

Alias
UMLS CUI [1]
C4478243
patients with contraindications to systemic anticoagulation with heparin or coumadin.
Description

Medical contraindication Anticoagulation Therapy Systemic | Medical contraindication Heparin | Medical contraindication Coumadin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003281
UMLS CUI [1,3]
C0205373
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0019134
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0699129
prior atrial fibrillation ablation.
Description

Catheter ablation for atrial fibrillation Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C0205156
patients who are or may potentially be pregnant.
Description

Pregnancy | Possible pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0425965
contraindication for adenosine administration;
Description

Medical contraindication Adenosine

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0001443
current enrollment in another investigational drug or device study.
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
pacemaker or implantable cardioverter defibrillator.
Description

Artificial cardiac pacemaker | Implantable cardioverter defibrillator

Data type

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0162589
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Similar models

Eligibility Atrial Fibrillation NCT02497248

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Paroxysmal atrial fibrillation Symptomatic | Anti-Arrhythmia Agents Quantity Unresponsive to Treatment
Item
patients with paroxysmal af symptomatic and refractory to at least one antiarrhythmic medication.
boolean
C0235480 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0003195 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
Persistent atrial fibrillation Symptomatic | Anti-Arrhythmia Agents Quantity Unresponsive to Treatment
Item
patients with persistent af symptomatic and refractory to at least one antiarrhythmic medication.
boolean
C2585653 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0003195 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
Mitral Stenosis Severe Stage | Mitral valve area | Thrombus of left atrium Absent | Moderate to severe mitral regurgitation Absent
Item
patients with severe mitral stenosis (mitral valve area ≤1.5 cm2, stage d) and favorable valve morphology in the absence of left atrial thrombus or moderate-to-severe mitral regurgitation.
boolean
C0026269 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1306673 (UMLS CUI [1,3])
C0428818 (UMLS CUI [2])
C3532827 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C4478243 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Informed Consent
Item
patients must be able and willing to provide written informed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Anticoagulation Therapy | Transesophageal Echocardiography Excludes Intracardiac thrombus
Item
prior anticoagulation for> 4 weeks or transesophageal echocardiogram excluding intracardiac thrombi (in patients with paroxysmal af).
boolean
C0003281 (UMLS CUI [1])
C0206054 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0876998 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Anticoagulation drug level Inadequate
Item
patients with inadequate anticoagulation levels.
boolean
C1168142 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
Thrombus of left atrium Excludes Catheterization | Neoplasm Excludes Catheterization | Abnormality Excludes Catheterization
Item
patients with left atrial thrombus, tumor, or another abnormality which precludes catheter introduction on tee prior to the procedure.
boolean
C3532827 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0007430 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0007430 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0007430 (UMLS CUI [3,3])
Mitral valve regurgitation, moderate to severe
Item
patients with moderate-to-severe mitral regurgitation.
boolean
C4478243 (UMLS CUI [1])
Medical contraindication Anticoagulation Therapy Systemic | Medical contraindication Heparin | Medical contraindication Coumadin
Item
patients with contraindications to systemic anticoagulation with heparin or coumadin.
boolean
C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0699129 (UMLS CUI [3,2])
Catheter ablation for atrial fibrillation Previous
Item
prior atrial fibrillation ablation.
boolean
C2702800 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Pregnancy | Possible pregnancy
Item
patients who are or may potentially be pregnant.
boolean
C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
Medical contraindication Adenosine
Item
contraindication for adenosine administration;
boolean
C1301624 (UMLS CUI [1,1])
C0001443 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
current enrollment in another investigational drug or device study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Artificial cardiac pacemaker | Implantable cardioverter defibrillator
Item
pacemaker or implantable cardioverter defibrillator.
boolean
C0030163 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
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