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SITELINE 2 Polyurethane

Primary Purpose

Bradycardia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SITELINE 2 Polyurethane (pacing lead)
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bradycardia focused on measuring Pacemaker leads, Electrodes, implantable, Cardiac pacing, aritificial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Multiple Locations in the United States

Outcomes

Primary Outcome Measures

Pacing voltage threshold at 3 Months
Pacing impedance at 3 Months
Sensed amplitude at 3 Months
Lead complication-free rate up to 3 Months

Secondary Outcome Measures

Full Information

First Posted
September 9, 2005
Last Updated
September 28, 2011
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00180284
Brief Title
SITELINE 2 Polyurethane
Official Title
SITELINE 2 Polyurethane Clinical Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

5. Study Description

Brief Summary
The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical performance of the 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia
Keywords
Pacemaker leads, Electrodes, implantable, Cardiac pacing, aritificial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
SITELINE 2 Polyurethane (pacing lead)
Intervention Description
SITELINE 2 Polyurethane (pacing lead)
Primary Outcome Measure Information:
Title
Pacing voltage threshold at 3 Months
Time Frame
3 months
Title
Pacing impedance at 3 Months
Time Frame
3 months
Title
Sensed amplitude at 3 Months
Time Frame
3 months
Title
Lead complication-free rate up to 3 Months
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Multiple Locations in the United States
City
St. Paul
State/Province
Minnesota
Country
United States

12. IPD Sharing Statement

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SITELINE 2 Polyurethane

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