Status:
COMPLETED
SITELINE 2 Polyurethane
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Bradycardia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical performance of the SITELINE 2 Polyurethane pacing lead.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00180284
Start Date
November 1 2004
End Date
February 1 2008
Last Update
September 29 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Multiple Locations in the United States
Saint Paul, Minnesota, United States