Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead

Study Overview
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Brief Summary
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The purpose of this clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead

Detailed Description
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This clinical study was a prospective, multi-center, clinical evaluation to document safety and effectiveness of the EASYTRAK 3 lead in humans. Patients implanted with the EASYTRAK 3 lead were followed through pre-discharge, 1-month, 3-month and 6-month follow-ups

Official Title
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Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Device: EASYTRAK 3 left ventricular pacing lead


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF <= 35%) and QRS duration >= 120 ms remaining symptomatic despite stable, optimal heart failure drug therapy. 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 investigational center and at the intervals defined by this protocol. Exclusion Criteria: A known hypersensitivity to a 1.0 mg (0.5 mg per electrode) dose of dexamethasone acetate. Previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement. Pre-existing cardioversion/defibrillation leads other than those specified in this investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads). Requiring dialysis. A myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment. Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis). A documented life expectancy of less than 6 months or expected to undergo heart transplant within 6 months. Enrolled in any concurrent study, without prior Guidant written approval, that may confound the results of this study. Have a mechanical tricuspid heart valve.

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 left ventricular pacing lead|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pacing thresholds at 6 months |  |  | 
| Pacing impedances at 6 months |  |  | 
| R-wave amplitudes at 6 months |  |  | 
| 6-month complication free rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial Cardiac Pacemaker, Implanted Electrodes