Heart Failure Clinical Trial

InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry

Summary

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.

When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (soft insulated wires) that are inserted through the veins to the heart.

The purpose of this study is to monitor the long-term performance of the InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) systems for cardiac resynchronization therapy (CRT).

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Full Description

Condition of Approval study for cardiac resynchronization therapy with pacemakers, and for the Attain left ventricular leads 2187, 2188, 4193, and 4194.

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Eligibility Criteria

Inclusion Criteria:

Patients implanted with an InSync Model 8040 or InSync III Model 8042, a right ventricular lead, and a Medtronic market-released left ventricular lead as part of a system to deliver cardiac resynchronization therapy.

Exclusion Criteria:

Patients with a history of a previously failed placement of a currently investigational Medtronic left ventricular lead within 30 days of enrollment in the InSync Registry

Study is for people with:

Heart Failure

Estimated Enrollment:

1999

Study ID:

NCT00273182

Recruitment Status:

Completed

Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

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There is 1 Location for this study

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Birmingham Alabama, , United States

Peoria Arizona, , United States

Ft. Smith Arkansas, , United States

Little Rock Arkansas, , United States

Long Beach California, , United States

Napa California, , United States

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Richmond Virginia, , United States

Virginia Beach Virginia, , United States

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Morgantown West Virginia, , United States

Milwaukee Wisconsin, , United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

1999

Study ID:

NCT00273182

Recruitment Status:

Completed

Sponsor:


Medtronic Cardiac Rhythm and Heart Failure

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