ID

37479

Description

Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study; ODM derived from: https://clinicaltrials.gov/show/NCT01203748

Link

https://clinicaltrials.gov/show/NCT01203748

Keywords

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

See clinicaltrials.gov

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August 1, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01203748

English

Eligibility Atrial Fibrillation NCT01203748

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients age is18 years or greater;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients undergoing a first-time ablation procedure for af;
Description

Catheter ablation for atrial fibrillation Firstly

Data type

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C1279901
patients with persistent af;
Description

Persistent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2585653
persistent af will be defined as a sustained episode lasting > 7 days and less than 3 years.
Description

Persistent atrial fibrillation Episode Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C2585653
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0449238
patients with symptomatic af that is refractory to at least one antiarrhythmic medication;
Description

ATRIAL FIBRILLATION SYMPTOMATIC | Unresponsive to Anti-Arrhythmia Agents Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0741283
UMLS CUI [2,1]
C0205269
UMLS CUI [2,2]
C0003195
UMLS CUI [2,3]
C1265611
at least one episode of persistent af must have been documented by ecg, holter, loop recorder, telemetry, trans telephonic monitoring (ttm), or implantable device within last 2 years of enrollment in this investigation;
Description

Persistent atrial fibrillation Episode Quantity ECG | Persistent atrial fibrillation Episode Quantity Holter Electrocardiography | Persistent atrial fibrillation Episode Quantity Loop recorder | Persistent atrial fibrillation Episode Quantity Telemetry | Other Coding | Persistent atrial fibrillation Episode Quantity Implant

Data type

boolean

Alias
UMLS CUI [1,1]
C2585653
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0013798
UMLS CUI [2,1]
C2585653
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0013801
UMLS CUI [3,1]
C2585653
UMLS CUI [3,2]
C0332189
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C3838353
UMLS CUI [4,1]
C2585653
UMLS CUI [4,2]
C0332189
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0039451
UMLS CUI [5]
C3846158
UMLS CUI [6,1]
C2585653
UMLS CUI [6,2]
C0332189
UMLS CUI [6,3]
C1265611
UMLS CUI [6,4]
C0021102
patients must be able and willing to provide written informed consent to participate in this investigation; and
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients must be willing and able to comply with all peri-ablation and follow-up requirements.
Description

Compliance Ablation | Compliance Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0547070
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C3274571
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with paroxysmal af;
Description

Paroxysmal atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0235480
patients with long-standing persistent af;
Description

Longstanding persistent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C3873617
patients for whom cardioversion or sinus rhythm will never be attempted/pursued;
Description

Electric Countershock Attempt Absent | Sinus rhythm Attempt Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0013778
UMLS CUI [1,2]
C1516084
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0232201
UMLS CUI [2,2]
C1516084
UMLS CUI [2,3]
C0332197
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
patients with contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor;
Description

Medical contraindication Anticoagulation Therapy Systemic | Medical contraindication Heparin | Medical contraindication Coumadin | Medical contraindication Direct Thrombin Inhibitor

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
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C3536847
patients with left atrial size ≥ 60 mm (2d echocardiography, parasternal long axis view); and
Description

Left atrium Size 2D Echocardiography | Left atrium Size Parasternal long axis view

Data type

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0013524
UMLS CUI [2,1]
C0225860
UMLS CUI [2,2]
C0456389
UMLS CUI [2,3]
C1302222
patients who are pregnant.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Atrial Fibrillation NCT01203748

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients age is18 years or greater;
boolean
C0001779 (UMLS CUI [1])
Catheter ablation for atrial fibrillation Firstly
Item
patients undergoing a first-time ablation procedure for af;
boolean
C2702800 (UMLS CUI [1,1])
C1279901 (UMLS CUI [1,2])
Persistent atrial fibrillation
Item
patients with persistent af;
boolean
C2585653 (UMLS CUI [1])
Persistent atrial fibrillation Episode Duration
Item
persistent af will be defined as a sustained episode lasting > 7 days and less than 3 years.
boolean
C2585653 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
ATRIAL FIBRILLATION SYMPTOMATIC | Unresponsive to Anti-Arrhythmia Agents Quantity
Item
patients with symptomatic af that is refractory to at least one antiarrhythmic medication;
boolean
C0741283 (UMLS CUI [1])
C0205269 (UMLS CUI [2,1])
C0003195 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Persistent atrial fibrillation Episode Quantity ECG | Persistent atrial fibrillation Episode Quantity Holter Electrocardiography | Persistent atrial fibrillation Episode Quantity Loop recorder | Persistent atrial fibrillation Episode Quantity Telemetry | Other Coding | Persistent atrial fibrillation Episode Quantity Implant
Item
at least one episode of persistent af must have been documented by ecg, holter, loop recorder, telemetry, trans telephonic monitoring (ttm), or implantable device within last 2 years of enrollment in this investigation;
boolean
C2585653 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0013798 (UMLS CUI [1,4])
C2585653 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0013801 (UMLS CUI [2,4])
C2585653 (UMLS CUI [3,1])
C0332189 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C3838353 (UMLS CUI [3,4])
C2585653 (UMLS CUI [4,1])
C0332189 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0039451 (UMLS CUI [4,4])
C3846158 (UMLS CUI [5])
C2585653 (UMLS CUI [6,1])
C0332189 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
C0021102 (UMLS CUI [6,4])
Informed Consent
Item
patients must be able and willing to provide written informed consent to participate in this investigation; and
boolean
C0021430 (UMLS CUI [1])
Compliance Ablation | Compliance Follow-up
Item
patients must be willing and able to comply with all peri-ablation and follow-up requirements.
boolean
C1321605 (UMLS CUI [1,1])
C0547070 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Paroxysmal atrial fibrillation
Item
patients with paroxysmal af;
boolean
C0235480 (UMLS CUI [1])
Longstanding persistent atrial fibrillation
Item
patients with long-standing persistent af;
boolean
C3873617 (UMLS CUI [1])
Electric Countershock Attempt Absent | Sinus rhythm Attempt Absent
Item
patients for whom cardioversion or sinus rhythm will never be attempted/pursued;
boolean
C0013778 (UMLS CUI [1,1])
C1516084 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0232201 (UMLS CUI [2,1])
C1516084 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
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])
Medical contraindication Anticoagulation Therapy Systemic | Medical contraindication Heparin | Medical contraindication Coumadin | Medical contraindication Direct Thrombin Inhibitor
Item
patients with contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor;
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])
C1301624 (UMLS CUI [4,1])
C3536847 (UMLS CUI [4,2])
Left atrium Size 2D Echocardiography | Left atrium Size Parasternal long axis view
Item
patients with left atrial size ≥ 60 mm (2d echocardiography, parasternal long axis view); and
boolean
C0225860 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0013524 (UMLS CUI [1,3])
C0225860 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C1302222 (UMLS CUI [2,3])
Pregnancy
Item
patients who are pregnant.
boolean
C0032961 (UMLS CUI [1])
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