ID

37572

Beschrijving

the Study of STABLE_SR for Persistent Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT01761188

Link

https://clinicaltrials.gov/show/NCT01761188

Trefwoorden

Versies (1)
  1. 08-08-19 08-08-19 -
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See clinicaltrials.gov

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8 augustus 2019

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Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01761188

Engels

Eligibility Atrial Fibrillation NCT01761188

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients undergoing a first-time ablation procedure for af;
Beschrijving

Catheter ablation for atrial fibrillation Firstly

Datatype

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C1279901
patients with persistent or long-lasting af; persistent af will be defined as a sustained episode lasting > 7 days and less than 1 years; long-lasting persistent af will be more than 1 year and less than 5 years.
Beschrijving

Persistent atrial fibrillation Episode Duration | Longstanding persistent atrial fibrillation Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C2585653
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C3873617
UMLS CUI [2,2]
C0449238
patients must be willing and able to comply with all peri-ablation and follow-up requirements.
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
patients with atrial fibrillation will to accept the procedure of ablation.
Beschrijving

Atrial Fibrillation | Agreement Ablation

Datatype

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C0680240
UMLS CUI [2,2]
C0547070
patients signed the written informed consent for the study.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
patients can endure the required follow up.
Beschrijving

Compliance Follow-up

Datatype

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with paroxysmal af; paroxysmal af will be defined as a sustained episode lasting < 7days.
Beschrijving

Paroxysmal atrial fibrillation Episode Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0235480
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0449238
patients with contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor.
Beschrijving

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

Datatype

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 thromboemboli in laa.
Beschrijving

Thromboembolus Left Atrial Appendage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040038
UMLS CUI [1,2]
C4284918
patients with left atrial size ≥ 55 mm (2d echocardiography, parasternal long-axis view).
Beschrijving

Left atrium Size 2D Echocardiography Parasternal long axis view

Datatype

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0013524
UMLS CUI [1,4]
C1302222
patients allergic for contrast or iodine.
Beschrijving

Contrast media allergy | Iodine allergy

Datatype

boolean

Alias
UMLS CUI [1]
C0570562
UMLS CUI [2]
C0571818
patients with the scr >3.5mg/dl or ccr < 30 ml/min
Beschrijving

Creatinine measurement, serum | Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
patients with life expectancy < 12 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
patients who are in the period of pregnant
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Atrial Fibrillation NCT01761188

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
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 Episode Duration | Longstanding persistent atrial fibrillation Duration
Item
patients with persistent or long-lasting af; persistent af will be defined as a sustained episode lasting > 7 days and less than 1 years; long-lasting persistent af will be more than 1 year and less than 5 years.
boolean
C2585653 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C3873617 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Protocol Compliance
Item
patients must be willing and able to comply with all peri-ablation and follow-up requirements.
boolean
C0525058 (UMLS CUI [1])
Atrial Fibrillation | Agreement Ablation
Item
patients with atrial fibrillation will to accept the procedure of ablation.
boolean
C0004238 (UMLS CUI [1])
C0680240 (UMLS CUI [2,1])
C0547070 (UMLS CUI [2,2])
Informed Consent
Item
patients signed the written informed consent for the study.
boolean
C0021430 (UMLS CUI [1])
Compliance Follow-up
Item
patients can endure the required follow up.
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Paroxysmal atrial fibrillation Episode Duration
Item
patients with paroxysmal af; paroxysmal af will be defined as a sustained episode lasting < 7days.
boolean
C0235480 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
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])
Thromboembolus Left Atrial Appendage
Item
patients with thromboemboli in laa.
boolean
C0040038 (UMLS CUI [1,1])
C4284918 (UMLS CUI [1,2])
Left atrium Size 2D Echocardiography Parasternal long axis view
Item
patients with left atrial size ≥ 55 mm (2d echocardiography, parasternal long-axis view).
boolean
C0225860 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0013524 (UMLS CUI [1,3])
C1302222 (UMLS CUI [1,4])
Contrast media allergy | Iodine allergy
Item
patients allergic for contrast or iodine.
boolean
C0570562 (UMLS CUI [1])
C0571818 (UMLS CUI [2])
Creatinine measurement, serum | Creatinine clearance measurement
Item
patients with the scr >3.5mg/dl or ccr < 30 ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Life Expectancy
Item
patients with life expectancy < 12 months
boolean
C0023671 (UMLS CUI [1])
Pregnancy
Item
patients who are in the period of pregnant
boolean
C0032961 (UMLS CUI [1])
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