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

NCT00273182 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1999

Last updated 2013-08-05

Study results available
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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).

Conditions

Interventions

DEVICE

InSync Model 8040

Subjects with sucessful implants of InSync Model 8040.

DEVICE

InSync III Model 8042

Subjects with successful implants of InSync III Model 8042

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • InSync Registry Study Leader · Medtronic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00273182 on ClinicalTrials.gov