EASYTRAK 3 left ventricular pacing lead in Congestive Heart Failure - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Congestive Heart Failure

Intervention / Treatment

Device: EASYTRAK 3 left ventricular pacing lead

Detailed Description

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

Study Type

Interventional

Enrollment

115

Phase

Phase 2
Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria