InSync III Marquis Model 7279 Cardioverter Defibrillator Cardiac Resynchronization System
NCT00271232 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 238
Last updated 2007-12-21
Summary
People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm. If the heart is beating too slowly or at an abnormal rhythm, an ICD can also pace the heart to return the heart to its normal rhythm.
The InSync III Marquis device can change the timing of when the left and right ventricles of the heart are paced to beat. This is called "V to V timing". V to V timing may further improve the pumping function of the heart. The purpose of this study is to determine whether or not this V to V timing feature of the InSync III Marquis system is safe and effective.
Conditions
Interventions
- DEVICE
-
Cardiac resynchronization therapy
Sponsors & Collaborators
-
Medtronic Cardiac Rhythm and Heart Failure
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-03-31
- Completion
- 2005-04-30
Countries
- United States
Study Locations
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