Indication Implantation of CRT-D | Indication Left heart Lead
Item
patient is indicated for implant of a crt-d device and left-heart lead per local indications (in us only this is based on class i and ii indications for crt-d implant per hrs/acc/aha guidelines)
boolean
C3146298 (UMLS CUI [1,1])
C1135480 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0225809 (UMLS CUI [2,2])
C0181586 (UMLS CUI [2,3])
Informed Consent | Informed Consent Patient Representative
Item
patient (or legally authorized representative) has signed and dated the study-specific consent form
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Age
Item
patient is 18 years of age or older, or is of legal age to give informed consent per local and national law
boolean
C0001779 (UMLS CUI [1])
Patient Available Follow-up visit
Item
patient is expected to remain available for follow-up visits
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0589121 (UMLS CUI [1,3])
Comprehension Study Protocol | Protocol Compliance
Item
patient understands the study and agrees to comply with study protocol
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Previously Implanted Cardiac Lead Left ventricle | Implant Attempt Previous | Adverse event Due to Implant Attempt
Item
patient has a previous lv lead implanted or previous implant attempt within 30 days of enrollment or has ongoing aes from a previous unsuccessful implant attempt
boolean
C3272252 (UMLS CUI [1,1])
C0225897 (UMLS CUI [1,2])
C0021102 (UMLS CUI [2,1])
C1516084 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C0877248 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0021102 (UMLS CUI [3,3])
C1516084 (UMLS CUI [3,4])
Medical contraindication Cardiac transvenous pacemaker | MECHANICAL HEART-VALVE Right sided
Item
patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
boolean
C1301624 (UMLS CUI [1,1])
C0336574 (UMLS CUI [1,2])
C0493527 (UMLS CUI [2,1])
C0444532 (UMLS CUI [2,2])
Heart Transplantation
Item
patient has had a heart transplant (note: patients waiting for heart transplants are allowed in the study)
boolean
C0018823 (UMLS CUI [1])
Medical contraindication Dexamethasone acetate Dose
Item
patient is contraindicated for < 1 mg dexamethasone acetate
boolean
C1301624 (UMLS CUI [1,1])
C0057598 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Study Subject Participation Status | Interference Investigational New Drugs | Interference Investigational Medical Device
Item
patient is currently enrolled or planning to participate in a potentially confounding drug or device study during the course of this study. (note: co-enrollment in concurrent studies may be allowed provided that documented pre-approval is obtained from medtronic's study manager)
boolean
C2348568 (UMLS CUI [1])
C0521102 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0521102 (UMLS CUI [3,1])
C2346570 (UMLS CUI [3,2])
Life Expectancy
Item
patient has a life expectancy less than 180 days
boolean
C0023671 (UMLS CUI [1])
Exclusion Criteria Law | Age | Pregnancy | Breast Feeding
Item
patient with exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.)
boolean
C0680251 (UMLS CUI [1,1])
C0220866 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
Childbearing Potential Requirement Pregnancy test negative
Item
in us, women of childbearing potential must have a negative pregnancy test 7 days prior to implant to be included
boolean
C3831118 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0427780 (UMLS CUI [1,3])
Thoracotomy Receive Unable
Item
patient is unable to tolerate an urgent thoracotomy
boolean
C0039991 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])