ID

35602

Beschreibung

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

Stichworte

Versionen (1)
  1. 11.03.19 11.03.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

11. März 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT02493205

Englisch

Eligibility Coronary Artery Disease NCT02493205

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Indication Cardiac Arrhythmia Monitoring | Cardiac monitor Implantable

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Age

Datentyp

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.
Beschreibung

Informed Consent | Health information Disclosure authorized by Patient

Datentyp

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
Beschreibung

Exclusion Criteria

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

Immune function Reduced | High risk of Communicable Disease

Datentyp

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.
Beschreibung

Communicable Disease | Resolution Lacking Communicable Disease

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Study Subject Participation Status Impact End Point

Datentyp

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.
Beschreibung

Supratherapeutic INR

Datentyp

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.
Beschreibung

Study Subject Participation Status Inappropriate

Datentyp

boolean

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

Life Expectancy

Datentyp

boolean

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

Pregnancy

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Protocol Compliance Unable

Datentyp

boolean

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

Eligibility Coronary Artery Disease NCT02493205

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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