InSync III Marquis Model 7279 Cardioverter Defibrillator Cardiac Resynchronization System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00271232|
Recruitment Status : Completed
First Posted : December 30, 2005
Last Update Posted : December 21, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: Cardiac resynchronization therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||InSync III Marquis Model 7279 Cardioverter Defibrillator Cardiac Resynchronization System|
|Study Start Date :||March 2003|
|Study Completion Date :||April 2005|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271232
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