SITELINE 2 Polyurethane

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00180284
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : September 29, 2011
Information provided by (Responsible Party):
Boston Scientific Corporation

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

Condition or disease Intervention/treatment Phase
Bradycardia Device: SITELINE 2 Polyurethane (pacing lead) Phase 3

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 humans

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SITELINE 2 Polyurethane Clinical Investigation
Study Start Date : November 2004
Actual Primary Completion Date : May 2005
Actual Study Completion Date : February 2008

Intervention Details:
  • Device: SITELINE 2 Polyurethane (pacing lead)
    SITELINE 2 Polyurethane (pacing lead)

Primary Outcome Measures :
  1. Pacing voltage threshold at 3 Months [ Time Frame: 3 months ]
  2. Pacing impedance at 3 Months [ Time Frame: 3 months ]
  3. Sensed amplitude at 3 Months [ Time Frame: 3 months ]
  4. Lead complication-free rate up to 3 Months [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00180284

United States, Minnesota
Multiple Locations in the United States
St. Paul, Minnesota, United States
Sponsors and Collaborators
Boston Scientific Corporation

Responsible Party: Boston Scientific Corporation Identifier: NCT00180284     History of Changes
Other Study ID Numbers: Clinicals0009
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 29, 2011
Last Verified: September 2011

Keywords provided by Boston Scientific Corporation:
Pacemaker leads
Electrodes, implantable
Cardiac pacing, aritificial

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes