Indication Implantation of CRT-D
Item
have a sjm promote crt-d (model 3207 or other model with similar functioning) system that was implanted at least 4 months prior to enrollment for an approved indication per acc/aha/hrs guidelines.
boolean
C3146298 (UMLS CUI [1,1])
C1135480 (UMLS CUI [1,2])
Informed Consent | Protocol Compliance
Item
have the ability to provide written informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluation.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Endocardial defibrillation lead Right atrium Bipolar | Endocardial defibrillation lead Right ventricle Bipolar | Endocardial defibrillation lead Left ventricle Bipolar
Item
have legally marketed bipolar right atrial and true bipolar right ventricular pacing defibrillation leads, and a legally marketed endocardial bipolar lv lead.
boolean
C3874720 (UMLS CUI [1,1])
C0225844 (UMLS CUI [1,2])
C0443156 (UMLS CUI [1,3])
C3874720 (UMLS CUI [2,1])
C0225883 (UMLS CUI [2,2])
C0443156 (UMLS CUI [2,3])
C3874720 (UMLS CUI [3,1])
C0225897 (UMLS CUI [3,2])
C0443156 (UMLS CUI [3,3])
Age
Item
be less than 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Medical condition Interferes with Intervention thoracic | Lung disease End-stage | Interstitial Lung Diseases Advanced | Pneumonia Episode Frequent
Item
have any medical condition that would interfere with intra-thoracic measurements such as end-stage pulmonary disease, advanced interstitial pulmonary disease, or frequent episodes of pneumonia.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C0817096 (UMLS CUI [1,4])
C0024115 (UMLS CUI [2,1])
C0205088 (UMLS CUI [2,2])
C0206062 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C0032285 (UMLS CUI [4,1])
C0332189 (UMLS CUI [4,2])
C0332183 (UMLS CUI [4,3])
Medical contraindication Catheterization of right heart
Item
have a contraindication for right heart catheterization.
boolean
C1301624 (UMLS CUI [1,1])
C0189896 (UMLS CUI [1,2])
Medical contraindication Nitroglycerin Intravenous
Item
have a contraindication for the delivery of iv nitroglycerin.
boolean
C1301624 (UMLS CUI [1,1])
C0017887 (UMLS CUI [1,2])
C1522726 (UMLS CUI [1,3])
Pregnancy | Pregnancy, Planned
Item
be pregnant or planning a pregnancy for the duration of their study participation.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Study Subject Participation Status | Treatment Arm Included
Item
be currently participating in a clinical investigation that includes an active treatment arm.
boolean
C2348568 (UMLS CUI [1])
C1522541 (UMLS CUI [2,1])
C0332257 (UMLS CUI [2,2])
Life Expectancy
Item
have a life expectancy of less than 12 months due to any condition.
boolean
C0023671 (UMLS CUI [1])
Valsalva Maneuver Airway pressure Perform Unable
Item
be unable to perform the valsalva maneuver with airway pressure > 40 mm hg for ≥10 seconds.
boolean
C0042293 (UMLS CUI [1,1])
C0428719 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Pacemaker Dependence | Pacemaker Cessation Resulting in Syncope | Pacemaker Cessation Resulting in Ventricular asystole
Item
are pacemaker dependent, where cessation of pacemaker function consistently results in syncope or ventricular asystole.
boolean
C0030163 (UMLS CUI [1,1])
C0439857 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2,1])
C1880019 (UMLS CUI [2,2])
C0332294 (UMLS CUI [2,3])
C0039070 (UMLS CUI [2,4])
C0030163 (UMLS CUI [3,1])
C1880019 (UMLS CUI [3,2])
C0332294 (UMLS CUI [3,3])
C0018790 (UMLS CUI [3,4])