ID

34789

Description

Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: The 1-2-3 Study; ODM derived from: https://clinicaltrials.gov/show/NCT02074566

Link

https://clinicaltrials.gov/show/NCT02074566

Keywords

Versions (1)
  1. 1/29/19 1/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 29, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02074566

English

Eligibility Atrial Fibrillation NCT02074566

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
paroxysmal atrial fibrillation eligible for pulmonary vein isolation according to current international guidelines.
Description

Paroxysmal atrial fibrillation | Eligibility Pulmonary vein isolation

Data type

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C3544330
age < 70 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
willing and able to sign informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
willing to and capable of following the requested study procedures.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
age < 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
life or follow-up expectancy < 12 months.
Description

Life Expectancy | Follow-up Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C1522577
UMLS CUI [2,2]
C0679138
previous pvi.
Description

Pulmonary vein isolation Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C3544330
UMLS CUI [1,2]
C0205156
contrast allergy.
Description

Contrast media allergy

Data type

boolean

Alias
UMLS CUI [1]
C0570562
creatin clearance level < 60.
Description

Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
left ventricular ejection fraction < 40%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
abnormal left atrium anatomy defined as number of pv's ≠ 4 or left atrium diameter >50mm (measured in the parasternal long axis, as assessed with transthoracic echocardiography) or >40 cc/m2 . this will lead to exclusion after inclusion but before randomisation.
Description

Left atrial structure Abnormal | Pulmonary veins Number | Left atrium Diameter Parasternal long axis view Transthoracic echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0205161
UMLS CUI [2,1]
C0034090
UMLS CUI [2,2]
C0237753
UMLS CUI [3,1]
C0225860
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C1302222
UMLS CUI [3,4]
C0430462
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Similar models

Eligibility Atrial Fibrillation NCT02074566

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Paroxysmal atrial fibrillation | Eligibility Pulmonary vein isolation
Item
paroxysmal atrial fibrillation eligible for pulmonary vein isolation according to current international guidelines.
boolean
C0235480 (UMLS CUI [1])
C1548635 (UMLS CUI [2,1])
C3544330 (UMLS CUI [2,2])
Age
Item
age < 70 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
willing and able to sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
willing to and capable of following the requested study procedures.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
age < 18 years.
boolean
C0001779 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Life Expectancy | Follow-up Expectancy
Item
life or follow-up expectancy < 12 months.
boolean
C0023671 (UMLS CUI [1])
C1522577 (UMLS CUI [2,1])
C0679138 (UMLS CUI [2,2])
Pulmonary vein isolation Previous
Item
previous pvi.
boolean
C3544330 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Contrast media allergy
Item
contrast allergy.
boolean
C0570562 (UMLS CUI [1])
Creatinine clearance measurement
Item
creatin clearance level < 60.
boolean
C0373595 (UMLS CUI [1])
Left ventricular ejection fraction
Item
left ventricular ejection fraction < 40%
boolean
C0428772 (UMLS CUI [1])
Left atrial structure Abnormal | Pulmonary veins Number | Left atrium Diameter Parasternal long axis view Transthoracic echocardiography
Item
abnormal left atrium anatomy defined as number of pv's ≠ 4 or left atrium diameter >50mm (measured in the parasternal long axis, as assessed with transthoracic echocardiography) or >40 cc/m2 . this will lead to exclusion after inclusion but before randomisation.
boolean
C0225860 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0034090 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C0225860 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C1302222 (UMLS CUI [3,3])
C0430462 (UMLS CUI [3,4])
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