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

Completed

Conditions studied: Heart Failure, Cardiomyopathy

In brief

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).

Key facts

Study ID

NCT00273182

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

1999

Starts

2002-03-01

Expected to finish

2011-04-01

Last updated by the study team

2013-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Peoria, Arizona, United States
• Study site — Fort Smith, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Long Beach, California, United States
• Study site — Napa, California, United States
• Study site — Oxnard, California, United States
• Study site — San Diego, California, United States
• Study site — Yuba City, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Melbourne, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Rockford, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Des Moines, Iowa, United States
• Study site — Kansas City, Kansas, United States
• Study site — Overland Park, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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