Informed Consent | confidentiality Authorization
Item
subject provides written informed consent and privacy/protection authorization.
boolean
C0021430 (UMLS CUI [1])
C0009669 (UMLS CUI [2,1])
C1524004 (UMLS CUI [2,2])
Age
Item
subjects 65 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Age | Cerebrovascular accident risk factors
Item
subjects with age >18 and < 65 years and one of the following stroke risk factors:
boolean
C0001779 (UMLS CUI [1])
C0038454 (UMLS CUI [2,1])
C0035648 (UMLS CUI [2,2])
Cerebrovascular accident | Transient Ischemic Attack
Item
prior stroke or tia
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Hypertensive disease
Item
diagnosis of hypertension (htn)
boolean
C0020538 (UMLS CUI [1])
Diabetes Mellitus
Item
diagnosis of diabetes mellitus (dm)
boolean
C0011849 (UMLS CUI [1])
Congestive heart failure
Item
diagnosis of congestive heart failure (chf)
boolean
C0018802 (UMLS CUI [1])
Indication PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | Indication Cardioverter-defibrillator, dual chamber (implantable)
Item
subjects who meet the class i/class ii indications for a dual chamber implantable pulse generator or dual chamber implanted cardioverter defibrillator device
boolean
C3146298 (UMLS CUI [1,1])
C0493526 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0993732 (UMLS CUI [2,2])
Indication Cardiac Resynchronization Therapy Devices | Atrio-Biventricular Pacing | Congestive heart failure Symptoms Moderate | Congestive heart failure Symptoms Severe | Therapeutic procedure Optimal | Left ventricular ejection fraction | QRS complex duration
Item
• subjects who meet the criteria for indication of a dual chamber resynchronization device with bi-ventricular pacing (moderate to severe chf symptoms [nyha class iii-iv] despite optimal medical therapy, left ventricular ejection fraction ≤ 35%, and a qrs duration ≥130 ms)13.
boolean
C3146298 (UMLS CUI [1,1])
C2936377 (UMLS CUI [1,2])
C2936372 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
C0205081 (UMLS CUI [3,3])
C0018802 (UMLS CUI [4,1])
C1457887 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
C0087111 (UMLS CUI [5,1])
C2698651 (UMLS CUI [5,2])
C0428772 (UMLS CUI [6])
C0429025 (UMLS CUI [7])
Replacement of electronic heart device, pulse generator | Replacement of cardioverter defibrillator | Surgical Replantation Cardiac Resynchronization Therapy Devices
Item
subjects who are to receive a replacement ipg, icd or crt device.
boolean
C0189853 (UMLS CUI [1])
C1998273 (UMLS CUI [2])
C0035139 (UMLS CUI [3,1])
C2936377 (UMLS CUI [3,2])
Atrial tachycardia Permanent | Permanent atrial fibrillation
Item
subjects with chronic (permanent) at/af.
boolean
C0546959 (UMLS CUI [1,1])
C0205355 (UMLS CUI [1,2])
C2586056 (UMLS CUI [2])
AV node arrhythmia
Item
subjects with a history of av nodal dependent arrhythmias.
boolean
C0264896 (UMLS CUI [1])
Terminal illness | Life Expectancy
Item
subjects with a terminal illness who are not expected to survive more than 6 months.
boolean
C0679247 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Compliance behavior Limited | Informed Consent Unable | Informed Consent Unwilling
Item
subjects who are unwilling or unable to cooperate or give written informed consent and privacy/protection authorization, or subjects whose legal representatives or legal guardians refuse to give informed consent or privacy/protection authorization.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
Study Subject Participation Status Affecting research results | Investigational New Drugs | Investigational Medical Device
Item
subjects currently receiving treatment in another drug and/or device study which could affect the outcome of the trial.
boolean
C2348568 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
follow-up Patient unavailable
Item
subjects who are or will be inaccessible for follow-up at a qualified study center.
boolean
C1522577 (UMLS CUI [1,1])
C1301818 (UMLS CUI [1,2])