SITELINE 2 Polyurethane

Boston Scientific

Status and phase: Completed; Phase 3

Conditions: Bradycardia

Treatments: Device: SITELINE 2 Polyurethane (pacing lead)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00180284

Clinicals0009

Details and patient eligibility

About

The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical performance of the SITELINE 2 Polyurethane pacing lead.

Full 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 humans

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)