Indication Medical Device
Item
indications for the device
boolean
C3146298 (UMLS CUI [1,1])
C0025080 (UMLS CUI [1,2])
Study Protocol Interval Follow-up Availability
Item
availability for follow-up at an approved field following center, at the protocol defined intervals
boolean
C2348563 (UMLS CUI [1,1])
C1272706 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
C0470187 (UMLS CUI [1,4])
Device implant Willing | Testing participation
Item
willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
boolean
C0948629 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0039593 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
Heart failure Pharmacotherapy Optimal Stable
Item
prescribed to stable optimal pharmacologic therapy for hf
boolean
C0018801 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C2698651 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Age | Informed Consent
Item
age 18 or above, or of legal age to give informed consent specific to national law
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Atrial Fibrillation Episode Quantity Evidence | Atrial Tachyarrhythmia Episode Quantity Evidence | Anticoagulation Therapy Recommended
Item
able to provide documented evidence of one or more episodes of af/at within 12 months of implantation note: guidant recommends anticoagulation therapy per physician discretion.
boolean
C0004238 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332120 (UMLS CUI [1,4])
C0080203 (UMLS CUI [2,1])
C0018792 (UMLS CUI [2,2])
C0332189 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0332120 (UMLS CUI [2,5])
C0003281 (UMLS CUI [3,1])
C0034866 (UMLS CUI [3,2])
Right bundle branch block Morphology
Item
right bundle branch block morphology
boolean
C0085615 (UMLS CUI [1,1])
C0332437 (UMLS CUI [1,2])
Life Expectancy Due to Other medical condition
Item
life expectancy of less than six months due to other medical conditions
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3843040 (UMLS CUI [1,3])
Heart Transplantation Expected
Item
expectation of a heart transplant during the period of the study
boolean
C0018823 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Mechanical heart valve prosthesis Tricuspid valve
Item
patients with or who are likely to receive a mechanical tricuspid valve during the course of the study
boolean
C3873910 (UMLS CUI [1,1])
C0040960 (UMLS CUI [1,2])
Artificial cardiac pacemaker Unipolar Pre-existing
Item
have a preexisting unipolar pacemaker that will not be explanted/abandoned
boolean
C0030163 (UMLS CUI [1,1])
C0443340 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
Atrial Tachyarrhythmia Permanent
Item
have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) within 180 days prior to enrollment
boolean
C0080203 (UMLS CUI [1,1])
C0018792 (UMLS CUI [1,2])
C0205355 (UMLS CUI [1,3])
Hypersensitivity dexamethasone acetate
Item
have a known hypersensitivity to dexamethasone acetate
boolean
C0020517 (UMLS CUI [1,1])
C0057598 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs
Item
enrolled in any other study, including drug investigation
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Pregnancy | Pregnancy, Planned
Item
women that are pregnant or planning to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Cerebrovascular accident | Transient Ischemic Attack
Item
a cerebral vascular event/ transient ischemic attack within 12 months of implantation
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Atrial Fibrillation Episode Duration | Anticoagulation Therapy Inadequate | International Normalized Ratio
Item
during the four weeks prior to implantation, a patient experiences an episode of af >= 48 hours in duration and was not anticoagulated for at an adequate therapeutic level (inr >= 2.0) for the 4 weeks prior to enrollment
boolean
C0004238 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0003281 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0525032 (UMLS CUI [3])