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

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

PHASE2/PHASE3

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2004-11-30

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

Conditions

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Congestive Heart Failure

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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EASYTRAK 3 left ventricular pacing lead

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Other Identifiers

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Clinicals0007

Identifier Type: -

Identifier Source: org_study_id