NCT00273182

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

InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Systems for Cardiac Resynchronization Therapy (CRT) - InSync Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,999 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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

Conditions

• Heart Failure
• Cardiomyopathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2002-03-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2006-01-09
• Last updated: 2013-08-05
• Results posted: 2013-08-05

Locations

82 sites across 1 country: United States