InSync III Marquis Model 7279 Cardioverter Defibrillator Cardiac Resynchronization System
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||InSync III Marquis Model 7279 Cardioverter Defibrillator Cardiac Resynchronization System|
- To evaluate the safety and effectiveness of the InSync III Marquis Model 7279 in heart failure patients who were indicated for an ICD
- Rate of oxygen uptake (consumption) measured during exercise, all adverse events, echocardiographic assessments (tests done using ultra sound to examine the health of the heart), and device performance
|Study Start Date:||March 2003|
|Estimated Study Completion Date:||April 2005|
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