InSync Implantable Cardioverter Defibrillator Registry: Cardiac Resynchronization Therapy
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|ClinicalTrials.gov Identifier: NCT00289302|
Recruitment Status : Completed
First Posted : February 9, 2006
Last Update Posted : October 5, 2007
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.
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 ICD device can change the timing of when the left and right ventricles of the heart are paced to beat.
The purpose of this study is to monitor the long-term performance of the InSync ICD Model 7272 and the InSync Marquis 7277 systems for cardiac resynchronization therapy (CRT).
|Condition or disease||Intervention/treatment|
|Heart Failure Cardiomyopathy||Device: Cardiac resynchronization therapy device|
|Study Type :||Observational|
|Enrollment :||600 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||InSync Implantable Cardioverter Defibrillator Registry: Cardiac Resynchronization Therapy|
|Study Start Date :||January 2003|
|Actual Study Completion Date :||December 2006|
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): NCT00289302
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|Study Chair:||InSync ICD Registry Study Leader||Medtronic|