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])
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])