SITELINE 2 Polyurethane

Last updated: September 28, 2011
Sponsor: Boston Scientific Corporation
Overall Status: Completed

Phase

3

Condition

Heart Defect

Cardiac Disease

Dysrhythmia

Treatment

N/A

Clinical Study ID

NCT00180284
Clinicals0009
  • Ages > 18
  • All Genders

Study Summary

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

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

Total Participants: 200
Study Start date:
November 01, 2004
Estimated Completion Date:
February 29, 2008

Study 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

Connect with a study center

  • Multiple Locations in the United States

    St. Paul, Minnesota
    United States

    Site Not Available

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