EASYTRAK 3 Downsize Lead

Study Overview
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Brief Summary
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The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 3 Downsize Lead.

Detailed Description
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This is a prospective, non-randomized, multi-center US clinical investigation, designed to demonstrate the safety and effectiveness of the Guidant EASYTRAK 3 Downsize Lead in humans.

Official Title
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EASYTRAK® 3 Downsize Lead Clinical Investigation

Conditions
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Heart Failure

Intervention / Treatment
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* Device: EASYTRAK 3 Downsize Lead


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be indicated for a Guidant CRT-P or CRT-D device Creatinine < 2.5 mg/dL obtained no more than two weeks prior to enrollment Age 18 or above, or of legal age to give informed consent specific to state and national law Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigation center and at the intervals defined by this protocol Geographically stable residents who are available for follow-up Exclusion Criteria: Have a known hypersensitivity to a 0.5 mg nominal dose of dexamethasone acetate Have or had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement Have pre-existing cardioversion/defibrillation leads or right ventricular pacing leads other than those specified in the investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads) Currently requiring dialysis Have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis) Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months Enrolled or participating in any concurrent study, including drug investigations, without Guidant written approval, that may confound the results of this study Have a pre-existing unipolar pacemaker that will not be explanted/abandoned Have a mechanical tricuspid heart valve Women who are pregnant or plan to become pregnant. Note: Women of childbearing potential must have a negative pregnancy test within seven days of enrollment.

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: EASYTRAK 3 Downsize Lead|EASYTRAK 3 Downsize Lead|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lead-related complication-free rate at one-month |  | 1 month | 
| Chronic mean pacing thresholds at one-month. |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic mean R-wave amplitudes at one-month |  | 1 month | 
| Chronic mean pacing impedances at one-month. |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left ventricular lead, Pacing, Heart Failure