ID

37628

Description

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

Keywords

  1. 8/12/19 8/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 12, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Atrial Fibrillation NCT02186704

Eligibility Atrial Fibrillation NCT02186704

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
fulfills standard indications for icd implantation
Description

Indication Implantable defibrillator insertion

Data type

boolean

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

Informed Consent | Informed Consent Patient Representative

Data type

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
Description

Implantation intended Cardiac monitoring Specified | Implantation Cardiac monitoring Specified

Data type

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
Description

Compliance Monitoring At home

Data type

boolean

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

Exclusion Criteria

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

Prior diagnosis Atrial Fibrillation | Prior diagnosis Atrial Flutter

Data type

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
Description

Patient need for Intra-atrial pacing

Data type

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
Description

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

Data type

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
Description

Compliance Unable Monitoring At home

Data type

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
Description

Pregnancy

Data type

boolean

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

Life Expectancy

Data type

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
Description

Implanted Medical Device cardiac | Exception Cardiac monitoring Specified

Data type

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
Description

Implantation Previous Cardiac monitoring Specified

Data type

boolean

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

Similar models

Eligibility Atrial Fibrillation NCT02186704

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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