ID

33292

Descrição

Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems; ODM derived from: https://clinicaltrials.gov/show/NCT01774357

Link

https://clinicaltrials.gov/show/NCT01774357

Palavras-chave

  1. 04/12/2018 04/12/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

4 de dezembro de 2018

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Atrial Fibrillation NCT01774357

Eligibility Atrial Fibrillation NCT01774357

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
indication for implantation of a single chamber icd (primary or secondary prevention) according to current guidelines
Descrição

Indication Implantation Single chamber cardioverter-defibrillator Primary Prevention | Indication Implantation Single chamber cardioverter-defibrillator Secondary Prevention

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0021107
UMLS CUI [1,3]
C0993733
UMLS CUI [1,4]
C0033144
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0021107
UMLS CUI [2,3]
C0993733
UMLS CUI [2,4]
C0679699
implanted with a biotronik lumax 540 vr-t dx icd with linoxsmart s dx or successor single chamber dx system within 90 days prior to enrollment
Descrição

Implantation Single chamber cardioverter-defibrillator Specified

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021107
UMLS CUI [1,2]
C0993733
UMLS CUI [1,3]
C0205369
written informed consent, willingness and ability to comply with the protocol
Descrição

Informed Consent | Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
age < 18 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
any limitation to contractual capability
Descrição

Contract Capability Limited

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332522
UMLS CUI [1,2]
C2698977
UMLS CUI [1,3]
C0439801
female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study
Descrição

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
known active malignant disease or recovered from malignant disease within 2 years prior to enrollment
Descrição

Malignant Neoplasms | Malignant Neoplasms Patient recovered

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C1115804
simultaneous participation in another study
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
life expectancy < 2 years
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671

Similar models

Eligibility Atrial Fibrillation NCT01774357

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Indication Implantation Single chamber cardioverter-defibrillator Primary Prevention | Indication Implantation Single chamber cardioverter-defibrillator Secondary Prevention
Item
indication for implantation of a single chamber icd (primary or secondary prevention) according to current guidelines
boolean
C3146298 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
C0993733 (UMLS CUI [1,3])
C0033144 (UMLS CUI [1,4])
C3146298 (UMLS CUI [2,1])
C0021107 (UMLS CUI [2,2])
C0993733 (UMLS CUI [2,3])
C0679699 (UMLS CUI [2,4])
Implantation Single chamber cardioverter-defibrillator Specified
Item
implanted with a biotronik lumax 540 vr-t dx icd with linoxsmart s dx or successor single chamber dx system within 90 days prior to enrollment
boolean
C0021107 (UMLS CUI [1,1])
C0993733 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Informed Consent | Protocol Compliance
Item
written informed consent, willingness and ability to comply with the protocol
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Age
Item
age < 18 years
boolean
C0001779 (UMLS CUI [1])
Contract Capability Limited
Item
any limitation to contractual capability
boolean
C0332522 (UMLS CUI [1,1])
C2698977 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Malignant Neoplasms | Malignant Neoplasms Patient recovered
Item
known active malignant disease or recovered from malignant disease within 2 years prior to enrollment
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C1115804 (UMLS CUI [2,2])
Study Subject Participation Status
Item
simultaneous participation in another study
boolean
C2348568 (UMLS CUI [1])
Life Expectancy
Item
life expectancy < 2 years
boolean
C0023671 (UMLS CUI [1])

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