ID

35602

Description

The Holding Area LINQ (Reveal LINQ Insertable Cardiac Monitor) Trial is a Prospective, Non-randomized, Single Center Post-market Clinical Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02493205

Link

https://clinicaltrials.gov/show/NCT02493205

Keywords

  1. 3/11/19 3/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 11, 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 Coronary Artery Disease NCT02493205

Eligibility Coronary Artery Disease NCT02493205

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient is indicated for continuous arrhythmia monitoring with an implantable cardiac monitor
Description

Indication Cardiac Arrhythmia Monitoring | Cardiac monitor Implantable

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0003811
UMLS CUI [1,3]
C0150369
UMLS CUI [2,1]
C0179608
UMLS CUI [2,2]
C0021102
2. patient is willing to undergo implant in holding area setting with only local anesthetic and/or oral anti-anxiety medications for sedation (2 mg of valium or ativan) at patient request.
Description

Implantation Willing | Local Anesthetic | Anti-Anxiety Agents Oral | Valium | Ativan

Data type

boolean

Alias
UMLS CUI [1,1]
C0021107
UMLS CUI [1,2]
C0600109
UMLS CUI [2]
C0002934
UMLS CUI [3,1]
C0040616
UMLS CUI [3,2]
C1527415
UMLS CUI [4]
C0699187
UMLS CUI [5]
C0699194
3. patient is 18 years of age or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. patient is willing to provide informed consent and authorize disclosure of personal health information in accordance with state and national regulations.
Description

Informed Consent | Health information Disclosure authorized by Patient

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0850397
UMLS CUI [2,2]
C0012625
UMLS CUI [2,3]
C1551374
UMLS CUI [2,4]
C0030705
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient has reduced immune function or is otherwise at high risk for infection
Description

Immune function Reduced | High risk of Communicable Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1817756
UMLS CUI [1,2]
C0392756
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0009450
2. patient has had a recent (within 30 days) or otherwise unresolved infection.
Description

Communicable Disease | Resolution Lacking Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C1514893
UMLS CUI [2,2]
C0332268
UMLS CUI [2,3]
C0009450
3. patient is implanted or indicated for implant with a pacemaker, implantable cardiac device (icd), cardiac resyncronization therapy (crt) or hemodynamic monitoring system.
Description

Pacemaker implant | Indication Pacemaker implant | Implantable defibrillator | Indication Implantable defibrillator | Cardiac Resynchronization Therapy | Indication Cardiac Resynchronization Therapy | Hemodynamic Monitoring System | Indication Hemodynamic Monitoring System

Data type

boolean

Alias
UMLS CUI [1]
C0848753
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0848753
UMLS CUI [3]
C0162589
UMLS CUI [4,1]
C3146298
UMLS CUI [4,2]
C0162589
UMLS CUI [5]
C1167956
UMLS CUI [6,1]
C3146298
UMLS CUI [6,2]
C1167956
UMLS CUI [7]
C4287143
UMLS CUI [8,1]
C3146298
UMLS CUI [8,2]
C4287143
4. patient is participating in another clinical trial that may have an impact on the trial endpoints.
Description

Study Subject Participation Status Impact End Point

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C2349179
5. patient has a super-therapeutic inr > 3.0.
Description

Supratherapeutic INR

Data type

boolean

Alias
UMLS CUI [1]
C4049341
6. patient considered by principal investigator and/or sub-investigator to be inappropriate for the trial for any reason.
Description

Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
7. patient's life expectancy is less than 1 year.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
8. patient is pregnant.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
9. patient has an unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure.
Description

Anatomic structure thoracic Unusual | Cicatrization Implant Site | At risk Implantation procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0700276
UMLS CUI [1,2]
C0817096
UMLS CUI [1,3]
C2700116
UMLS CUI [2,1]
C0008767
UMLS CUI [2,2]
C0021102
UMLS CUI [2,3]
C1515974
UMLS CUI [3,1]
C1444641
UMLS CUI [3,2]
C0021107
10. inability to comply with planned trial procedures
Description

Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582

Similar models

Eligibility Coronary Artery Disease NCT02493205

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Indication Cardiac Arrhythmia Monitoring | Cardiac monitor Implantable
Item
1. patient is indicated for continuous arrhythmia monitoring with an implantable cardiac monitor
boolean
C3146298 (UMLS CUI [1,1])
C0003811 (UMLS CUI [1,2])
C0150369 (UMLS CUI [1,3])
C0179608 (UMLS CUI [2,1])
C0021102 (UMLS CUI [2,2])
Implantation Willing | Local Anesthetic | Anti-Anxiety Agents Oral | Valium | Ativan
Item
2. patient is willing to undergo implant in holding area setting with only local anesthetic and/or oral anti-anxiety medications for sedation (2 mg of valium or ativan) at patient request.
boolean
C0021107 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0002934 (UMLS CUI [2])
C0040616 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0699187 (UMLS CUI [4])
C0699194 (UMLS CUI [5])
Age
Item
3. patient is 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Health information Disclosure authorized by Patient
Item
4. patient is willing to provide informed consent and authorize disclosure of personal health information in accordance with state and national regulations.
boolean
C0021430 (UMLS CUI [1])
C0850397 (UMLS CUI [2,1])
C0012625 (UMLS CUI [2,2])
C1551374 (UMLS CUI [2,3])
C0030705 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Immune function Reduced | High risk of Communicable Disease
Item
1. patient has reduced immune function or is otherwise at high risk for infection
boolean
C1817756 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0332167 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])
Communicable Disease | Resolution Lacking Communicable Disease
Item
2. patient has had a recent (within 30 days) or otherwise unresolved infection.
boolean
C0009450 (UMLS CUI [1])
C1514893 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0009450 (UMLS CUI [2,3])
Pacemaker implant | Indication Pacemaker implant | Implantable defibrillator | Indication Implantable defibrillator | Cardiac Resynchronization Therapy | Indication Cardiac Resynchronization Therapy | Hemodynamic Monitoring System | Indication Hemodynamic Monitoring System
Item
3. patient is implanted or indicated for implant with a pacemaker, implantable cardiac device (icd), cardiac resyncronization therapy (crt) or hemodynamic monitoring system.
boolean
C0848753 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0848753 (UMLS CUI [2,2])
C0162589 (UMLS CUI [3])
C3146298 (UMLS CUI [4,1])
C0162589 (UMLS CUI [4,2])
C1167956 (UMLS CUI [5])
C3146298 (UMLS CUI [6,1])
C1167956 (UMLS CUI [6,2])
C4287143 (UMLS CUI [7])
C3146298 (UMLS CUI [8,1])
C4287143 (UMLS CUI [8,2])
Study Subject Participation Status Impact End Point
Item
4. patient is participating in another clinical trial that may have an impact on the trial endpoints.
boolean
C2348568 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C2349179 (UMLS CUI [1,3])
Supratherapeutic INR
Item
5. patient has a super-therapeutic inr > 3.0.
boolean
C4049341 (UMLS CUI [1])
Study Subject Participation Status Inappropriate
Item
6. patient considered by principal investigator and/or sub-investigator to be inappropriate for the trial for any reason.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
Life Expectancy
Item
7. patient's life expectancy is less than 1 year.
boolean
C0023671 (UMLS CUI [1])
Pregnancy
Item
8. patient is pregnant.
boolean
C0032961 (UMLS CUI [1])
Anatomic structure thoracic Unusual | Cicatrization Implant Site | At risk Implantation procedure
Item
9. patient has an unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure.
boolean
C0700276 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
C2700116 (UMLS CUI [1,3])
C0008767 (UMLS CUI [2,1])
C0021102 (UMLS CUI [2,2])
C1515974 (UMLS CUI [2,3])
C1444641 (UMLS CUI [3,1])
C0021107 (UMLS CUI [3,2])
Protocol Compliance Unable
Item
10. inability to comply with planned trial procedures
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])

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