SITELINE 2 Polyurethane

SITELINE 2 Polyurethane Clinical Investigation

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

Study Overview

• Status: Completed
• Conditions: Bradycardia
• Intervention / Treatment: Device: 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

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • St. Paul, Minnesota, United States
      • Multiple Locations in the United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pacing voltage threshold at 3 Months	3 months
Pacing impedance at 3 Months	3 months
Sensed amplitude at 3 Months	3 months
Lead complication-free rate up to 3 Months	3 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): May 1, 2005
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): September 29, 2011
• Last Update Submitted That Met QC Criteria: September 28, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Pacemaker leads; Electrodes, implantable; Cardiac pacing, aritificial
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: Clinicals0009