Status:
COMPLETED
InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Cardiomyopathy
Eligibility:
All Genders
18+ years
Brief 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 th...
Detailed Description
Condition of Approval study for cardiac resynchronization therapy with pacemakers, and for the Attain left ventricular leads 2187, 2188, 4193, and 4194.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
1999 Patients enrolled
Trial Details
Trial ID
NCT00273182
Start Date
March 1 2002
End Date
April 1 2011
Last Update
August 5 2013
Active Locations (82)
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1
Birmingham, Alabama, United States
2
Peoria, Arizona, United States
3
Fort Smith, Arkansas, United States
4
Little Rock, Arkansas, United States