SITELINE 2 Polyurethane

Study Overview
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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

Official Title
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SITELINE 2 Polyurethane Clinical Investigation

Conditions
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Bradycardia

Intervention / Treatment
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* Device: SITELINE 2 Polyurethane (pacing lead)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SITELINE 2 Polyurethane (pacing lead)|SITELINE 2 Polyurethane (pacing lead)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacemaker leads, Electrodes, implantable, Cardiac pacing, aritificial