ID

37663

Description

Cryoballoon Pulmonary Venous Isolation in Patients Referred for Typical Atrial Flutter Ablation; ODM derived from: https://clinicaltrials.gov/show/NCT01521988

Link

https://clinicaltrials.gov/show/NCT01521988

Keywords

Versions (1)
  1. 8/14/19 8/14/19 -
Copyright Holder

See clinicaltrials.gov

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August 14, 2019

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License

Creative Commons BY 4.0
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Eligibility Atrial Flutter NCT01521988

English

Eligibility Atrial Flutter NCT01521988

1 forms  
Criteria
Description

Criteria

patient with a spontaneous flutter or with a flutter recurrence when it was not considered appropriate to use a preventive treatment so far. the flutter may have been paroxysmal or may still be present.
Description

Atrial Flutter Spontaneous | ATRIAL FLUTTER RECURRENT | Paroxysmal atrial flutter | Atrial Flutter

Data type

boolean

Alias
UMLS CUI [1,1]
C0004239
UMLS CUI [1,2]
C0205359
UMLS CUI [2]
C0741293
UMLS CUI [3]
C0741292
UMLS CUI [4]
C0004239
patient with at least one documented episode of typical flutter defined as follows: negative f waves in the inferior territory, positive in v1 and negative in v6 lead, f wave pattern with characteristic "saw tooth" appearance and finally a heart rate comprised between 240 and 320 beats per minute.
Description

Atrial Flutter Episode Quantity | F-wave finding | Lead site V1 Positive | Lead site V6 Negative | Heart rate

Data type

boolean

Alias
UMLS CUI [1,1]
C0004239
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0429368
UMLS CUI [3,1]
C0441907
UMLS CUI [3,2]
C1514241
UMLS CUI [4,1]
C0449220
UMLS CUI [4,2]
C1513916
UMLS CUI [5]
C0018810
patient with effective anticoagulant therapy for at least 3 weeks.
Description

Anticoagulant therapy Effective

Data type

boolean

Alias
UMLS CUI [1,1]
C0150457
UMLS CUI [1,2]
C1280519
patient with at least one episode of af (lasting more than 1 minute) documented on an ecg or a 24 hour holter recording
Description

Atrial Fibrillation Episode Quantity Electrocardiography | Atrial Flutter Episode Quantity 24 Hour Holter tape

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C1623258
UMLS CUI [2,1]
C0004239
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0430461
patient who signed an informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patient with age ≥ 18 yo and ≤ 75 yo
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
exclusion criteria:
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
patients with the following characteristics will be excluded:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
contraindication to right-heart catheterization
Description

Medical contraindication Catheterization of right heart

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0189896
contraindication to an anticoagulant treatment
Description

Medical contraindication Anticoagulant therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0150457
patient for which af is predominant (more recordings of af than flutter)
Description

Atrial Fibrillation predominant

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C1542147
persistent af at the time of inclusion visit
Description

Persistent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2585653
history of mitral valve surgery
Description

Mitral valve operation

Data type

boolean

Alias
UMLS CUI [1]
C0519382
known disorders of blood clotting
Description

Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005779
cardiothyreosis
Description

Thyrotoxic heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0264792
life expectancy < 24 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
less than 18 years old and pregnant ladies. as before any ablation, a pregnancy test will be done the day before or the day of the procedure
Description

Age | Pregnancy Pregnancy Test

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0032976
patient less than 18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient under guardianship
Description

Patients Guardianship

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0870627
patient deprived of their liberty by a court decision
Description

Patients Deprivation Freedom

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0871712
UMLS CUI [1,3]
C0016694
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Similar models

Eligibility Atrial Flutter NCT01521988

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Atrial Flutter Spontaneous | ATRIAL FLUTTER RECURRENT | Paroxysmal atrial flutter | Atrial Flutter
Item
patient with a spontaneous flutter or with a flutter recurrence when it was not considered appropriate to use a preventive treatment so far. the flutter may have been paroxysmal or may still be present.
boolean
C0004239 (UMLS CUI [1,1])
C0205359 (UMLS CUI [1,2])
C0741293 (UMLS CUI [2])
C0741292 (UMLS CUI [3])
C0004239 (UMLS CUI [4])
Atrial Flutter Episode Quantity | F-wave finding | Lead site V1 Positive | Lead site V6 Negative | Heart rate
Item
patient with at least one documented episode of typical flutter defined as follows: negative f waves in the inferior territory, positive in v1 and negative in v6 lead, f wave pattern with characteristic "saw tooth" appearance and finally a heart rate comprised between 240 and 320 beats per minute.
boolean
C0004239 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0429368 (UMLS CUI [2])
C0441907 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C0449220 (UMLS CUI [4,1])
C1513916 (UMLS CUI [4,2])
C0018810 (UMLS CUI [5])
Anticoagulant therapy Effective
Item
patient with effective anticoagulant therapy for at least 3 weeks.
boolean
C0150457 (UMLS CUI [1,1])
C1280519 (UMLS CUI [1,2])
Atrial Fibrillation Episode Quantity Electrocardiography | Atrial Flutter Episode Quantity 24 Hour Holter tape
Item
patient with at least one episode of af (lasting more than 1 minute) documented on an ecg or a 24 hour holter recording
boolean
C0004238 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1623258 (UMLS CUI [1,4])
C0004239 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0430461 (UMLS CUI [2,4])
Informed Consent
Item
patient who signed an informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
patient with age ≥ 18 yo and ≤ 75 yo
boolean
C0001779 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion criteria:
boolean
C0680251 (UMLS CUI [1])
Client Characteristics
Item
patients with the following characteristics will be excluded:
boolean
C0815172 (UMLS CUI [1])
Medical contraindication Catheterization of right heart
Item
contraindication to right-heart catheterization
boolean
C1301624 (UMLS CUI [1,1])
C0189896 (UMLS CUI [1,2])
Medical contraindication Anticoagulant therapy
Item
contraindication to an anticoagulant treatment
boolean
C1301624 (UMLS CUI [1,1])
C0150457 (UMLS CUI [1,2])
Atrial Fibrillation predominant
Item
patient for which af is predominant (more recordings of af than flutter)
boolean
C0004238 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Persistent atrial fibrillation
Item
persistent af at the time of inclusion visit
boolean
C2585653 (UMLS CUI [1])
Mitral valve operation
Item
history of mitral valve surgery
boolean
C0519382 (UMLS CUI [1])
Blood Coagulation Disorders
Item
known disorders of blood clotting
boolean
C0005779 (UMLS CUI [1])
Thyrotoxic heart disease
Item
cardiothyreosis
boolean
C0264792 (UMLS CUI [1])
Life Expectancy
Item
life expectancy < 24 months
boolean
C0023671 (UMLS CUI [1])
Age | Pregnancy Pregnancy Test
Item
less than 18 years old and pregnant ladies. as before any ablation, a pregnancy test will be done the day before or the day of the procedure
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
Age
Item
patient less than 18 years old
boolean
C0001779 (UMLS CUI [1])
Patients Guardianship
Item
patient under guardianship
boolean
C0030705 (UMLS CUI [1,1])
C0870627 (UMLS CUI [1,2])
Patients Deprivation Freedom
Item
patient deprived of their liberty by a court decision
boolean
C0030705 (UMLS CUI [1,1])
C0871712 (UMLS CUI [1,2])
C0016694 (UMLS CUI [1,3])
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