EASYTRAK 4 STEERABLE LV lead in Heart Failure - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Heart Failure

Intervention / Treatment

Device: EASYTRAK 4 STEERABLE LV lead

Detailed Description

This is a prospective, multi-center clinical study is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.

Study Type

Interventional

Enrollment

110

Phase

Phase 2
Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Minnesota
  - St.Paul, Minnesota, United States
    - Multiple locations

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:

Must receive a commercially available 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 1.0 mg (0.5 mg per electrode) 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.

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
Lead-related complication free-rate at 3-months.
Chronic mean pacing thresholds at 3-months.

Secondary Outcome Measures

Outcome Measure
Chronic Mean pacing impedances at 3-months
Chronic Mean R-wave amplitudes at 3-months

Collaborators and Investigators

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

Sponsor

Boston Scientific Corporation

Investigators

Principal Investigator: Stephen Mester, MD, Tampa General Hospital

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

March 1, 2005

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria