ID

34789

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02074566

Nyckelord

  1. 2019-01-29 2019-01-29 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

29 januari 2019

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Atrial Fibrillation NCT02074566

Eligibility Atrial Fibrillation NCT02074566

Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Paroxysmal atrial fibrillation | Eligibility Pulmonary vein isolation

Datatyp

boolean

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

Age

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

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

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
age < 18 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

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

Life Expectancy | Follow-up Expectancy

Datatyp

boolean

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

Pulmonary vein isolation Previous

Datatyp

boolean

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

Contrast media allergy

Datatyp

boolean

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

Creatinine clearance measurement

Datatyp

boolean

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

Left ventricular ejection fraction

Datatyp

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.
Beskrivning

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

Datatyp

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

Similar models

Eligibility Atrial Fibrillation NCT02074566

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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