SITELINE 2 Polyurethane
Completed · Phase 3
Conditions studied: Bradycardia
In brief
The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical performance of the SITELINE 2 Polyurethane pacing lead.
Key facts
- Study ID
- NCT00180284
- Run by
- Boston Scientific Corporation
- People needed
- 200
- Starts
- 2004-11-01
- Expected to finish
- 2008-02-01
- Last updated by the study team
- 2011-09-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Women who are pregnant or plan to become pregnant
Where it is running
- Multiple Locations in the United States — Saint Paul, Minnesota, United States
Full record on ClinicalTrials.gov
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