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])
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])