ID

19371

Descrição

SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction; ODM derived from: https://clinicaltrials.gov/show/NCT00284830

Link

https://clinicaltrials.gov/show/NCT00284830

Palavras-chave

Versões (1)
  1. 22/12/2016 22/12/2016 -
Transferido a

22 de dezembro de 2016

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.

Voltar para os comentários do modelo
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 Sick Sinus Syndrome NCT00284830

Inglês

Eligibility Sick Sinus Syndrome NCT00284830

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age and older
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
willing and able to give informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
willing and able to comply with the study follow-up schedule
Descrição

Clinical Study Follow-up Compliance behavior

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1321605
class i/classii indications for dual chamber pacing
Descrição

Indication Dual Chamber Pacemaker Class

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2911683
UMLS CUI [1,3]
C3272276
initial implant of a kappa 700, kappa 900, enpulse, or enrhythm dual chamber ipg
Descrição

DUAL CHAMBER IMPLANTABLE PULSE-GENERATOR Implantation Initial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0493526
UMLS CUI [1,2]
C0021107
UMLS CUI [1,3]
C0205265
demonstrate 1 to 1 conduction and a qrs interval of < 120ms at 100 beats per minutes for a period of nine seconds while atrial pacing
Descrição

1:1 atrioventricular conduction | QRS interval | Intra-atrial pacing

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2215915
UMLS CUI [2]
C2168881
UMLS CUI [3]
C0199647
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
less than 18 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
unwilling or unable to give informed consent
Descrição

Informed Consent Unable | Informed Consent Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
unwilling or unable to commit to follow-up schedule
Descrição

Clinical Study Follow-up Compliance behavior Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0332268
medical conditions that would preclude the testing required by the protocol or limit study participation
Descrição

Medical condition Excludes Testing | Medical condition Limiting Clinical Trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0039593
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0008976
enrolled or intend to participate in another clinical trial during the course of this study
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
a life expectancy of less than 2 years
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
history of continuous atrial fibrillation for the 6 months prior to screen visit
Descrição

Atrial Fibrillation disease length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0872146
two or more cardioversions, chemical or electrical, within the past 6 months prior to screen
Descrição

Chemical cardioversion Quantity | Electric Countershock Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2585199
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0013778
UMLS CUI [2,2]
C1265611
history of persistent second or third degree atrioventricular block
Descrição

Second degree atrioventricular block persistent | Complete atrioventricular block persistent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0264906
UMLS CUI [1,2]
C0205322
UMLS CUI [2,1]
C0151517
UMLS CUI [2,2]
C0205322
a prior implant of pacemaker or defibrillator device
Descrição

Implantation of cardiac pacemaker | Implantation of cardiac defibrillator

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0189842
UMLS CUI [2]
C0397417
a baseline, pre-paced qrs >120 ms on surface ecg
Descrição

Electrocardiogram QRS complex

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0429098
failure of the 1 to 1 atrioventricular conduction test
Descrição

1:1 atrioventricular conduction Test failed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2215915
UMLS CUI [1,2]
C0039593
UMLS CUI [1,3]
C0231175
anticipated major cardiac surgery within the course of the study
Descrição

Cardiac Surgery Major Anticipated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C3840775
Voltar ao início da página

Similar models

Eligibility Sick Sinus Syndrome NCT00284830

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years of age and older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
willing and able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Clinical Study Follow-up Compliance behavior
Item
willing and able to comply with the study follow-up schedule
boolean
C3274571 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Indication Dual Chamber Pacemaker Class
Item
class i/classii indications for dual chamber pacing
boolean
C3146298 (UMLS CUI [1,1])
C2911683 (UMLS CUI [1,2])
C3272276 (UMLS CUI [1,3])
DUAL CHAMBER IMPLANTABLE PULSE-GENERATOR Implantation Initial
Item
initial implant of a kappa 700, kappa 900, enpulse, or enrhythm dual chamber ipg
boolean
C0493526 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
1:1 atrioventricular conduction | QRS interval | Intra-atrial pacing
Item
demonstrate 1 to 1 conduction and a qrs interval of < 120ms at 100 beats per minutes for a period of nine seconds while atrial pacing
boolean
C2215915 (UMLS CUI [1])
C2168881 (UMLS CUI [2])
C0199647 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Age
Item
less than 18 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent Unable | Informed Consent Unwilling
Item
unwilling or unable to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Clinical Study Follow-up Compliance behavior Lacking
Item
unwilling or unable to commit to follow-up schedule
boolean
C3274571 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Medical condition Excludes Testing | Medical condition Limiting Clinical Trial
Item
medical conditions that would preclude the testing required by the protocol or limit study participation
boolean
C3843040 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
Study Subject Participation Status
Item
enrolled or intend to participate in another clinical trial during the course of this study
boolean
C2348568 (UMLS CUI [1])
Life Expectancy
Item
a life expectancy of less than 2 years
boolean
C0023671 (UMLS CUI [1])
Atrial Fibrillation disease length
Item
history of continuous atrial fibrillation for the 6 months prior to screen visit
boolean
C0004238 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Chemical cardioversion Quantity | Electric Countershock Quantity
Item
two or more cardioversions, chemical or electrical, within the past 6 months prior to screen
boolean
C2585199 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0013778 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Second degree atrioventricular block persistent | Complete atrioventricular block persistent
Item
history of persistent second or third degree atrioventricular block
boolean
C0264906 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0151517 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
Implantation of cardiac pacemaker | Implantation of cardiac defibrillator
Item
a prior implant of pacemaker or defibrillator device
boolean
C0189842 (UMLS CUI [1])
C0397417 (UMLS CUI [2])
Electrocardiogram QRS complex
Item
a baseline, pre-paced qrs >120 ms on surface ecg
boolean
C0429098 (UMLS CUI [1])
1:1 atrioventricular conduction Test failed
Item
failure of the 1 to 1 atrioventricular conduction test
boolean
C2215915 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Cardiac Surgery Major Anticipated
Item
anticipated major cardiac surgery within the course of the study
boolean
C0018821 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C3840775 (UMLS CUI [1,3])
Voltar ao início da página 

Contacto

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

Campos marcados com * são obrigatórios.

Ajuda

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