Phase
Condition
Heart Defect
Cardiac Disease
Dysrhythmia
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients indicated for dual chamber pulse generator implant, where the pulse generatoris capable of meeting the requirements of this investigational protocol
Patients selected must have the study lead as the initial implant of a permanentpacing lead in both the right atrium and the right ventricle
Age 18 or above, or of legal age to give informed consent specific to state andnational law
Willing and capable of undergoing a device implant and participating in all testingassociated with this clinical investigation
Available for follow-up at an approved clinical investigational center, at theprotocol-defined intervals
A life expectancy of more than 180 days
Exclusion
Exclusion Criteria:
Have or who are likely to receive a mechanical tricuspid valve during the course ofthe clinical investigation
Have surgically uncorrected primary valvular heart disease
Have an atrial tachyarrhythmia that is permanent (i.e., does not terminatespontaneously and cannot be terminated with medical intervention) or persistent (i.e.,can be terminated with medical intervention, but does not terminate spontaneously)
Requiring ICD therapy
Have a hypersensitivity to a nominal single dose of 1.0 mg (0.5 mg per electrode) ofdexamethasone acetate drug
Enrolled in any concurrent study, including drug investigation, without Guidantwritten approval, that may confound the results of this study
Women who are pregnant or plan to become pregnant
Study Design
Study Description
Connect with a study center
Multiple Locations in the United States
St. Paul, Minnesota
United StatesSite Not Available
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