ID

37628

Beschrijving

Sensing Atrial High Rate Episodes With Implantable Cardioverter-Defibrillators Trial (The SENSE Trial); ODM derived from: https://clinicaltrials.gov/show/NCT02186704

Link

https://clinicaltrials.gov/show/NCT02186704

Trefwoorden

Versies (1)
  1. 12-08-19 12-08-19 -
Houder van rechten

See clinicaltrials.gov

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12 augustus 2019

DOI

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Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02186704

Engels

Eligibility Atrial Fibrillation NCT02186704

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
fulfills standard indications for icd implantation
Beschrijving

Indication Implantable defibrillator insertion

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0877213
subject or legally authorized representative can provide written authorization per institutional requirements
Beschrijving

Informed Consent | Informed Consent Patient Representative

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
subject is intended to be implanted with a complete biotronik dx system (consisting of a biotronik ilesto 7 vr-t dx icd or any future fda approved lumax vr-t dx icd, and the biotronik linox smart s dx lead), or has been implanted with a complete biotronik dx system no more than 30 days prior to the date of consent
Beschrijving

Implantation intended Cardiac monitoring Specified | Implantation Cardiac monitoring Specified

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021107
UMLS CUI [1,2]
C1283828
UMLS CUI [1,3]
C0150496
UMLS CUI [1,4]
C0205369
UMLS CUI [2,1]
C0021107
UMLS CUI [2,2]
C0150496
UMLS CUI [2,3]
C0205369
able to comply with home monitoring
Beschrijving

Compliance Monitoring At home

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C4534363
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has prior diagnosis of atrial fibrillation or atrial flutter
Beschrijving

Prior diagnosis Atrial Fibrillation | Prior diagnosis Atrial Flutter

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332132
UMLS CUI [1,2]
C0004238
UMLS CUI [2,1]
C0332132
UMLS CUI [2,2]
C0004239
subject has need for atrial pacing
Beschrijving

Patient need for Intra-atrial pacing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0199647
subject unwilling or unable to give informed consent or participate in follow-up
Beschrijving

Informed Consent Unwilling | Informed Consent Unable | Participation Follow-up Unwilling | Participation Follow-up Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C0679823
UMLS CUI [3,2]
C3274571
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C0679823
UMLS CUI [4,2]
C3274571
UMLS CUI [4,3]
C1299582
subject is unable to comply with home monitoring
Beschrijving

Compliance Unable Monitoring At home

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C1283169
UMLS CUI [1,4]
C4534363
subject is pregnant
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
subject has less than one year estimated life expectancy
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
subject was implanted with a cardiac device capable of detecting ahres prior to implantation of the biotronik dx system
Beschrijving

Implanted Medical Device cardiac | Exception Cardiac monitoring Specified

Datatype

boolean

Alias
UMLS CUI [1,1]
C2828363
UMLS CUI [1,2]
C0018787
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0150496
UMLS CUI [2,3]
C0205369
subject was implanted with biotronik dx system and had an ahre detection before enrollment
Beschrijving

Implantation Previous Cardiac monitoring Specified

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021107
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0150496
UMLS CUI [1,4]
C0205369
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Similar models

Eligibility Atrial Fibrillation NCT02186704

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Indication Implantable defibrillator insertion
Item
fulfills standard indications for icd implantation
boolean
C3146298 (UMLS CUI [1,1])
C0877213 (UMLS CUI [1,2])
Informed Consent | Informed Consent Patient Representative
Item
subject or legally authorized representative can provide written authorization per institutional requirements
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Implantation intended Cardiac monitoring Specified | Implantation Cardiac monitoring Specified
Item
subject is intended to be implanted with a complete biotronik dx system (consisting of a biotronik ilesto 7 vr-t dx icd or any future fda approved lumax vr-t dx icd, and the biotronik linox smart s dx lead), or has been implanted with a complete biotronik dx system no more than 30 days prior to the date of consent
boolean
C0021107 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
C0150496 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
C0021107 (UMLS CUI [2,1])
C0150496 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Compliance Monitoring At home
Item
able to comply with home monitoring
boolean
C1321605 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C4534363 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Prior diagnosis Atrial Fibrillation | Prior diagnosis Atrial Flutter
Item
subject has prior diagnosis of atrial fibrillation or atrial flutter
boolean
C0332132 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0332132 (UMLS CUI [2,1])
C0004239 (UMLS CUI [2,2])
Patient need for Intra-atrial pacing
Item
subject has need for atrial pacing
boolean
C0686904 (UMLS CUI [1,1])
C0199647 (UMLS CUI [1,2])
Informed Consent Unwilling | Informed Consent Unable | Participation Follow-up Unwilling | Participation Follow-up Unable
Item
subject unwilling or unable to give informed consent or participate in follow-up
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0679823 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0679823 (UMLS CUI [4,1])
C3274571 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
Compliance Unable Monitoring At home
Item
subject is unable to comply with home monitoring
boolean
C1321605 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C1283169 (UMLS CUI [1,3])
C4534363 (UMLS CUI [1,4])
Pregnancy
Item
subject is pregnant
boolean
C0032961 (UMLS CUI [1])
Life Expectancy
Item
subject has less than one year estimated life expectancy
boolean
C0023671 (UMLS CUI [1])
Implanted Medical Device cardiac | Exception Cardiac monitoring Specified
Item
subject was implanted with a cardiac device capable of detecting ahres prior to implantation of the biotronik dx system
boolean
C2828363 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0150496 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Implantation Previous Cardiac monitoring Specified
Item
subject was implanted with biotronik dx system and had an ahre detection before enrollment
boolean
C0021107 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0150496 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
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