ID

44722

Description

Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System; ODM derived from: https://clinicaltrials.gov/show/NCT01965899

Link

https://clinicaltrials.gov/show/NCT01965899

Keywords

Versions (1)
  1. 9/28/21 9/28/21 -
Copyright Holder

Medtronic Cardiac Rhythm and Heart Failure

Uploaded on

September 28, 2021

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Syncope NCT01965899

English

Eligibility Syncope NCT01965899

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Syncope NCT01965899
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is willing to sign and date the consent form.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
subject is indicated for a reveal device within the existing market approved indications
Description

An indication for an Implantation of patient-activated cardiac event recorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0812481
UMLS CUI [1,2]
C3146298
phase i (initial 30 subjects): any indication for a reveal linq device
Description

Phase I: Any indication for an Implantation of patient-activated cardiac event recorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0282459
UMLS CUI [1,2]
C0812481
UMLS CUI [1,3]
C3146298
phase ii (after the initial 30 subjects): subject has atrial fibrillation and is indicated for and identified as an af pre-ablation candidate (note: atrial fibrillation must be documented in the subject's medical history.)
Description

Phase II: subject has atrial fibrillation and is identified as an pre-ablation candidate

Data type

boolean

Alias
UMLS CUI [1,1]
C0282460
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0004238
UMLS CUI [1,4]
C0162563
subject has a life expectancy of 18 months or more.
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
subject is willing and able to set up and utilize mycarelink® home monitor and be remotely monitored (i.e., medtronic carelink® network)
Description

Subject is willing and able to be remotely monitored in a home environment

Data type

boolean

Alias
UMLS CUI [1,1]
C0442519
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C0600109
UMLS CUI [1,4]
C0085732
Women with a childbearing potential must have a negative pregnancy test at enrollment.
Description

Women with a childbearing potential must have a negative pregnancy test at enrollment.

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032976
UMLS CUI [1,3]
C0205160
Women with a childbearing potential must not be breastfeeding.
Description

Women with a childbearing potential must not be breastfeeding

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0006147
UMLS CUI [1,3]
C0332197
Women with a childbearing potential must either be surgically sterile, postmenopausal (cessation of menses for at least 1 year), or agree to use a medically accepted, highly effective method of contraception during the entire duration of the study.
Description

Female Sterilization | Postmenopausal women | Contraceptive Methods

Data type

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has an active implanted cardiac medical device (e.g., ipg, icd, crt, etc).
Description

Implanted cardiac medical device

Data type

boolean

Alias
UMLS CUI [1,1]
C2828363
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0475264
subject is unwilling or unable to comply with the study procedures
Description

Protocol compliance unable or unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C0558080
subject is legally incapacitated and unable to provide written informed consent.
Description

Subject is legally incapacitated | Informed consent unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional/psychological diagnosis)
Description

Other medical condition limiting the participation in the study

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
patient is enrolled in another study that could confound the results of this study, without documented pre-approval from medtronic study manager.
Description

Enrolling in another study that could confound the results of this study, without documented pre-approval from medtronic study manager.

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0683954
UMLS CUI [1,5]
C0335141
UMLS CUI [1,6]
C2346845
UMLS CUI [1,7]
C0332197
local law prohibits participation (e.g., minor status as specified by local law)
Description

Local law prohibits participation

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0220866
UMLS CUI [1,3]
C0205276
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Similar models

Eligibility Syncope NCT01965899

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Syncope NCT01965899
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
subject is willing to sign and date the consent form.
boolean
C0021430 (UMLS CUI [1])
An indication for an Implantation of patient-activated cardiac event recorder
Item
subject is indicated for a reveal device within the existing market approved indications
boolean
C0812481 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Phase I: Any indication for an Implantation of patient-activated cardiac event recorder
Item
phase i (initial 30 subjects): any indication for a reveal linq device
boolean
C0282459 (UMLS CUI [1,1])
C0812481 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Phase II: subject has atrial fibrillation and is identified as an pre-ablation candidate
Item
phase ii (after the initial 30 subjects): subject has atrial fibrillation and is indicated for and identified as an af pre-ablation candidate (note: atrial fibrillation must be documented in the subject's medical history.)
boolean
C0282460 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
C0162563 (UMLS CUI [1,4])
Life expectancy
Item
subject has a life expectancy of 18 months or more.
boolean
C0023671 (UMLS CUI [1])
Subject is willing and able to be remotely monitored in a home environment
Item
subject is willing and able to set up and utilize mycarelink® home monitor and be remotely monitored (i.e., medtronic carelink® network)
boolean
C0442519 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0085732 (UMLS CUI [1,4])
Women with a childbearing potential must have a negative pregnancy test at enrollment.
Item
Women with a childbearing potential must have a negative pregnancy test at enrollment.
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0205160 (UMLS CUI [1,3])
Women with a childbearing potential must not be breastfeeding
Item
Women with a childbearing potential must not be breastfeeding.
boolean
C3831118 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Female Sterilization | Postmenopausal women | Contraceptive Methods
Item
Women with a childbearing potential must either be surgically sterile, postmenopausal (cessation of menses for at least 1 year), or agree to use a medically accepted, highly effective method of contraception during the entire duration of the study.
boolean
C0015787 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Implanted cardiac medical device
Item
subject has an active implanted cardiac medical device (e.g., ipg, icd, crt, etc).
boolean
C2828363 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0475264 (UMLS CUI [1,3])
Protocol compliance unable or unwilling
Item
subject is unwilling or unable to comply with the study procedures
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Subject is legally incapacitated | Informed consent unable
Item
subject is legally incapacitated and unable to provide written informed consent.
boolean
C0683673 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Other medical condition limiting the participation in the study
Item
any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional/psychological diagnosis)
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Enrolling in another study that could confound the results of this study, without documented pre-approval from medtronic study manager.
Item
patient is enrolled in another study that could confound the results of this study, without documented pre-approval from medtronic study manager.
boolean
C2348568 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C0335141 (UMLS CUI [1,5])
C2346845 (UMLS CUI [1,6])
C0332197 (UMLS CUI [1,7])
Local law prohibits participation
Item
local law prohibits participation (e.g., minor status as specified by local law)
boolean
C0680251 (UMLS CUI [1,1])
C0220866 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
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