ID

37558

Descrição

DEtermining Accuracy and TrEnding CharacTerization of AF; ODM derived from: https://clinicaltrials.gov/show/NCT01673256

Link

https://clinicaltrials.gov/show/NCT01673256

Palavras-chave

Versões (1)
  1. 07/08/2019 07/08/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

7 de agosto de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01673256

Inglês

Eligibility Atrial Fibrillation NCT01673256

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
the subject has been implanted with a sjm confirm icm, dm2102.
Descrição

Implantable cardiac monitor Specified Implanted

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3879681
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0021102
the subject has or is suspected to have paroxysmal af.
Descrição

Paroxysmal atrial fibrillation | Paroxysmal atrial fibrillation Suspected

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2,1]
C0235480
UMLS CUI [2,2]
C0750491
the subject is ≥ 18 years of age.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
the subject is willing and able to provide written informed consent (prior to any investigational related procedure).
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
the subject has persistent (>7 days and ≤1 year or requiring cardioversion), longstanding persistent (continuous af >1 year) or permanent af (not attempting to restore sinus rhythm).
Descrição

Persistent atrial fibrillation Disease length | Persistent atrial fibrillation Requirement Electric Countershock | Longstanding persistent atrial fibrillation Disease length | Permanent atrial fibrillation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2585653
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C2585653
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0013778
UMLS CUI [3,1]
C3873617
UMLS CUI [3,2]
C0872146
UMLS CUI [4]
C2586056
the subject has af of reversible etiology (e.g. electrolyte imbalance, thyroid disease).
Descrição

Atrial Fibrillation Etiology Reversible | Electrolyte imbalance | Thyroid Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0205343
UMLS CUI [2]
C0342579
UMLS CUI [3]
C0040128
the subject has a contraindication to holter recording.
Descrição

Medical contraindication Holter Electrocardiography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013801
the subject has already received an active implantable medical device other than the sjm confirm icm, dm2102.
Descrição

Implant Received | Exception Implantable cardiac monitor Specified

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C1514756
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3879681
UMLS CUI [2,3]
C0205369
the subject is unable to comply with the follow up schedule.
Descrição

Compliance behavior Follow-up Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C3274571
UMLS CUI [1,3]
C1299582
the subject is participating in another investigational device or drug investigation.
Descrição

Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2346570
UMLS CUI [3]
C0013230
the subject is pregnant or is planning to become pregnant during the duration of the investigation.
Descrição

Pregnancy | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
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Similar models

Eligibility Atrial Fibrillation NCT01673256

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Implantable cardiac monitor Specified Implanted
Item
the subject has been implanted with a sjm confirm icm, dm2102.
boolean
C3879681 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0021102 (UMLS CUI [1,3])
Paroxysmal atrial fibrillation | Paroxysmal atrial fibrillation Suspected
Item
the subject has or is suspected to have paroxysmal af.
boolean
C0235480 (UMLS CUI [1])
C0235480 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Age
Item
the subject is ≥ 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
the subject is willing and able to provide written informed consent (prior to any investigational related procedure).
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Persistent atrial fibrillation Disease length | Persistent atrial fibrillation Requirement Electric Countershock | Longstanding persistent atrial fibrillation Disease length | Permanent atrial fibrillation
Item
the subject has persistent (>7 days and ≤1 year or requiring cardioversion), longstanding persistent (continuous af >1 year) or permanent af (not attempting to restore sinus rhythm).
boolean
C2585653 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C2585653 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0013778 (UMLS CUI [2,3])
C3873617 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
C2586056 (UMLS CUI [4])
Atrial Fibrillation Etiology Reversible | Electrolyte imbalance | Thyroid Disease
Item
the subject has af of reversible etiology (e.g. electrolyte imbalance, thyroid disease).
boolean
C0004238 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0205343 (UMLS CUI [1,3])
C0342579 (UMLS CUI [2])
C0040128 (UMLS CUI [3])
Medical contraindication Holter Electrocardiography
Item
the subject has a contraindication to holter recording.
boolean
C1301624 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
Implant Received | Exception Implantable cardiac monitor Specified
Item
the subject has already received an active implantable medical device other than the sjm confirm icm, dm2102.
boolean
C0021102 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C3879681 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Compliance behavior Follow-up Unable
Item
the subject is unable to comply with the follow up schedule.
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs
Item
the subject is participating in another investigational device or drug investigation.
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Pregnancy | Pregnancy, Planned
Item
the subject is pregnant or is planning to become pregnant during the duration of the investigation.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
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