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The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical performance of the SITELINE 2 Polyurethane pacing lead.
Condition or disease
Device: SITELINE 2 Polyurethane (pacing lead)
This was a prospective, single-arm, multi-center U.S. clinical investigation, designed to demonstrate the safety and effectiveness of the SITELINE 2 Polyurethane extendable, retractable pacing lead in humans
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients indicated for dual chamber pulse generator implant, where the pulse generator is capable of meeting the requirements of this investigational protocol
Patients selected must have the study lead as the initial implant of a permanent pacing 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 and national law
Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
Available for follow-up at an approved clinical investigational center, at the protocol-defined intervals
A life expectancy of more than 180 days
Have or who are likely to receive a mechanical tricuspid valve during the course of the clinical investigation
Have surgically uncorrected primary valvular heart disease
Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously 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) of dexamethasone acetate drug
Enrolled in any concurrent study, including drug investigation, without Guidant written approval, that may confound the results of this study