ID

37663

Descrição

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

Palavras-chave

  1. 14/08/2019 14/08/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

14 de agosto de 2019

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Atrial Flutter NCT01521988

Eligibility Atrial Flutter NCT01521988

Criteria
Descrição

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.
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

Anticoagulant therapy Effective

Tipo de dados

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
Descrição

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

Tipo de dados

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.
Descrição

Informed Consent

Tipo de dados

boolean

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

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
exclusion criteria:
Descrição

Exclusion Criteria

Tipo de dados

boolean

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

Client Characteristics

Tipo de dados

boolean

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

Medical contraindication Catheterization of right heart

Tipo de dados

boolean

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

Medical contraindication Anticoagulant therapy

Tipo de dados

boolean

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

Atrial Fibrillation predominant

Tipo de dados

boolean

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

Persistent atrial fibrillation

Tipo de dados

boolean

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

Mitral valve operation

Tipo de dados

boolean

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

Blood Coagulation Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005779
cardiothyreosis
Descrição

Thyrotoxic heart disease

Tipo de dados

boolean

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

Life Expectancy

Tipo de dados

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
Descrição

Age | Pregnancy Pregnancy Test

Tipo de dados

boolean

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

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patient under guardianship
Descrição

Patients Guardianship

Tipo de dados

boolean

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

Patients Deprivation Freedom

Tipo de dados

boolean

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

Similar models

Eligibility Atrial Flutter NCT01521988

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial