ID

34802

Descrição

Evaluate the Amount of Effective Cardiac Resynchronization Therapy (CRT) Pacing During AF; ODM derived from: https://clinicaltrials.gov/show/NCT02222818

Link

https://clinicaltrials.gov/show/NCT02222818

Palavras-chave

Versões (1)
  1. 29/01/2019 29/01/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

29 de janeiro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02222818

Inglês

Eligibility Atrial Fibrillation NCT02222818

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is willing to sign and date the study patient informed consent form.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
subject is at least 18 years of age (or older, if required by local law).
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
subject is expected to remain available after enrollment to complete follow-up visits in both arms of the study
Descrição

Patient Available Follow-up visits

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0589121
subject has had a medtronic viva or brava crt-d device implanted at least 30 days prior to enrollment.
Descrição

Implantation of CRT-D

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1135480
subject has history of af burden, of at least 6 days of at least 4 hours of af over any 4 week period within the last 90 days as documented in device diagnostic data or if subject has no atrial lead (therefore no device diagnostic data) but clinical evidence of high af burden.
Descrição

Atrial Fibrillation Burden High

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C2828008
UMLS CUI [1,3]
C0205250
subject has demonstrated history of being able to complete left ventricular capture management (lvcm) documented in device data.
Descrição

Other Coding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3846158
subject has a documented % v pacing during af of less than or equal to 97% within 90 days prior to enrollment or within 10 days after enrollment.
Descrição

Ventricular pacing pattern Percentage During Atrial Fibrillation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0429115
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0004238
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has undergone av node ablation for treatment of af.
Descrição

Ablation of atrioventricular node Treating Atrial Fibrillation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1998174
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C0004238
subject has complete or 3rd degree av block.
Descrição

Complete atrioventricular block

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151517
subject has had an mi within 30 days.
Descrição

Myocardial Infarction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
subject has medical conditions that limit study participation (per physician discretion).
Descrição

Medical condition Limiting Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C2348568
subject is enrolled in one or more concurrent studies that could confound the study results as determined by medtronic.
Descrição

Study Subject Participation Status Interferes with Research results

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
subject has a limited life expectancy for non-cardiac causes that would not allow completion of the study.
Descrição

Life Expectancy Limited | Cause cardiac Excluded | Completion of clinical trial failing

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0439801
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0018787
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C2732579
UMLS CUI [3,2]
C0231175
subject is pregnant (in the us, all women of child-bearing potential must undergo a pregnancy test within seven days prior to crtee download).
Descrição

Pregnancy | Childbearing Potential Pregnancy Test mandatory

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032976
UMLS CUI [2,3]
C1514873
subject meets the exclusion criteria required by local law.
Descrição

Exclusion Criteria Legal Fulfill

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1301860
UMLS CUI [1,3]
C1550543
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Similar models

Eligibility Atrial Fibrillation NCT02222818

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
subject is willing to sign and date the study patient informed consent form.
boolean
C0021430 (UMLS CUI [1])
Age
Item
subject is at least 18 years of age (or older, if required by local law).
boolean
C0001779 (UMLS CUI [1])
Patient Available Follow-up visits
Item
subject is expected to remain available after enrollment to complete follow-up visits in both arms of the study
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0589121 (UMLS CUI [1,3])
Implantation of CRT-D
Item
subject has had a medtronic viva or brava crt-d device implanted at least 30 days prior to enrollment.
boolean
C1135480 (UMLS CUI [1])
Atrial Fibrillation Burden High
Item
subject has history of af burden, of at least 6 days of at least 4 hours of af over any 4 week period within the last 90 days as documented in device diagnostic data or if subject has no atrial lead (therefore no device diagnostic data) but clinical evidence of high af burden.
boolean
C0004238 (UMLS CUI [1,1])
C2828008 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
Other Coding
Item
subject has demonstrated history of being able to complete left ventricular capture management (lvcm) documented in device data.
boolean
C3846158 (UMLS CUI [1])
Ventricular pacing pattern Percentage During Atrial Fibrillation
Item
subject has a documented % v pacing during af of less than or equal to 97% within 90 days prior to enrollment or within 10 days after enrollment.
boolean
C0429115 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0004238 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Ablation of atrioventricular node Treating Atrial Fibrillation
Item
subject has undergone av node ablation for treatment of af.
boolean
C1998174 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
Complete atrioventricular block
Item
subject has complete or 3rd degree av block.
boolean
C0151517 (UMLS CUI [1])
Myocardial Infarction
Item
subject has had an mi within 30 days.
boolean
C0027051 (UMLS CUI [1])
Medical condition Limiting Study Subject Participation Status
Item
subject has medical conditions that limit study participation (per physician discretion).
boolean
C3843040 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Study Subject Participation Status Interferes with Research results
Item
subject is enrolled in one or more concurrent studies that could confound the study results as determined by medtronic.
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Life Expectancy Limited | Cause cardiac Excluded | Completion of clinical trial failing
Item
subject has a limited life expectancy for non-cardiac causes that would not allow completion of the study.
boolean
C0023671 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0018787 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C2732579 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
Pregnancy | Childbearing Potential Pregnancy Test mandatory
Item
subject is pregnant (in the us, all women of child-bearing potential must undergo a pregnancy test within seven days prior to crtee download).
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
Exclusion Criteria Legal Fulfill
Item
subject meets the exclusion criteria required by local law.
boolean
C0680251 (UMLS CUI [1,1])
C1301860 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
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