SITELINE 2 Polyurethane

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00180284
First received: September 9, 2005
Last updated: September 28, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Bradycardia
Device: SITELINE 2 Polyurethane (pacing lead)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SITELINE 2 Polyurethane Clinical Investigation

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Pacing voltage threshold at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Pacing impedance at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Sensed amplitude at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Lead complication-free rate up to 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: November 2004
Study Completion Date: February 2008
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: SITELINE 2 Polyurethane (pacing lead)
    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 humans

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180284

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

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00180284     History of Changes
Other Study ID Numbers: Clinicals0009
Study First Received: September 9, 2005
Last Updated: September 28, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 19, 2014