SITELINE 2 Polyurethane

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2008-02-29

Brief Summary

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

Detailed Description

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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

Conditions

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Bradycardia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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SITELINE 2 Polyurethane (pacing lead)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Multiple Locations in the United States

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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Clinicals0009

Identifier Type: -

Identifier Source: org_study_id