ID

19529

Description

STAR-AF:Substrate Versus Trigger Ablation for Reduction of Atrial Fibrillation Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00367757

Link

https://clinicaltrials.gov/show/NCT00367757

Keywords

Versions (1)
  1. 1/7/17 1/7/17 -
Uploaded on

January 7, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00367757

English

Eligibility Atrial Fibrillation NCT00367757

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients age 18 or greater.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
"high burden" of paroxysmal atrial fibrillation or persistent atrial fibrillation
Description

Paroxysmal atrial fibrillation Severe | Persistent atrial fibrillation Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0235480
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C2585653
UMLS CUI [2,2]
C0205082
candidates for af ablation based on af that is symptomatic and refractory to at least one antiarrhythmic medication.
Description

Indication Ablation for atrial fibrillation | ATRIAL FIBRILLATION SYMPTOMATIC | Anti-Arrhythmia Agents Quantity Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2702800
UMLS CUI [2]
C0741283
UMLS CUI [3,1]
C0003195
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0205269
at least one episode of af must have been documented by ecg or holter within 12 months of randomization in the trial.
Description

Atrial Fibrillation Episode Quantity | Electrocardiography | Holter Electrocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C1623258
UMLS CUI [3]
C0013801
continuous anticoagulation with warfarin (inr 2-3) for >4 weeks prior to the ablation.
Description

Anticoagulation Therapy | Warfarin

Data type

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2]
C0043031
patients must be able and willing to provide written informed consent to participate in the clinical trial.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
chronic atrial fibrillation.
Description

Chronic atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0694539
patients with af felt to be secondary to an obvious reversible cause.
Description

Atrial Fibrillation Secondary to Cause Reversible

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0205343
inadequate anticoagulation as defined in the inclusion criteria.
Description

Anticoagulation Therapy Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C0205412
left atrial thrombus or spontaneous echo contrast on tee prior to procedure.
Description

Thrombus of left atrium | Transesophageal echocardiography with contrast Spontaneous

Data type

boolean

Alias
UMLS CUI [1]
C3532827
UMLS CUI [2,1]
C2585900
UMLS CUI [2,2]
C0205359
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
previously undergone atrial fibrillation ablation.
Description

ablation for atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2702800
left atrial size > 55 mm.
Description

Left atrium size

Data type

boolean

Alias
UMLS CUI [1,1]
C1269894
UMLS CUI [1,2]
C0456389
patients who are or may potentially be pregnant
Description

Pregnancy | Pregnancy Possible

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332149
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Similar models

Eligibility Atrial Fibrillation NCT00367757

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients age 18 or greater.
boolean
C0001779 (UMLS CUI [1])
Paroxysmal atrial fibrillation Severe | Persistent atrial fibrillation Severe
Item
"high burden" of paroxysmal atrial fibrillation or persistent atrial fibrillation
boolean
C0235480 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2585653 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Indication Ablation for atrial fibrillation | ATRIAL FIBRILLATION SYMPTOMATIC | Anti-Arrhythmia Agents Quantity Unresponsive to Treatment
Item
candidates for af ablation based on af that is symptomatic and refractory to at least one antiarrhythmic medication.
boolean
C3146298 (UMLS CUI [1,1])
C2702800 (UMLS CUI [1,2])
C0741283 (UMLS CUI [2])
C0003195 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0205269 (UMLS CUI [3,3])
Atrial Fibrillation Episode Quantity | Electrocardiography | Holter Electrocardiography
Item
at least one episode of af must have been documented by ecg or holter within 12 months of randomization in the trial.
boolean
C0004238 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1623258 (UMLS CUI [2])
C0013801 (UMLS CUI [3])
Anticoagulation Therapy | Warfarin
Item
continuous anticoagulation with warfarin (inr 2-3) for >4 weeks prior to the ablation.
boolean
C0003281 (UMLS CUI [1])
C0043031 (UMLS CUI [2])
Informed Consent
Item
patients must be able and willing to provide written informed consent to participate in the clinical trial.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chronic atrial fibrillation
Item
chronic atrial fibrillation.
boolean
C0694539 (UMLS CUI [1])
Atrial Fibrillation Secondary to Cause Reversible
Item
patients with af felt to be secondary to an obvious reversible cause.
boolean
C0004238 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0205343 (UMLS CUI [1,4])
Anticoagulation Therapy Inadequate
Item
inadequate anticoagulation as defined in the inclusion criteria.
boolean
C0003281 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
Thrombus of left atrium | Transesophageal echocardiography with contrast Spontaneous
Item
left atrial thrombus or spontaneous echo contrast on tee prior to procedure.
boolean
C3532827 (UMLS CUI [1])
C2585900 (UMLS CUI [2,1])
C0205359 (UMLS CUI [2,2])
Medical contraindication Anticoagulation Therapy Systemic | Medical contraindication Heparin | Medical contraindication Coumadin
Item
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])
ablation for atrial fibrillation
Item
previously undergone atrial fibrillation ablation.
boolean
C2702800 (UMLS CUI [1])
Left atrium size
Item
left atrial size > 55 mm.
boolean
C1269894 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Pregnancy | Pregnancy Possible
Item
patients who are or may potentially be pregnant
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
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