The primary objective is to determine if lead positioning in the lateral wall of the left ventricle in patients meeting criteria for cardiac resynchronization therapy plays a role in determining myocardial function and affects the severity of mitral regurgitation.
This is a 6 month, multi-centered, blinded, randomized study. Approximately 60 patients will join this study. Two groups, based on lead position, will be studied with thirty (30) patients randomized into each group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
A device implant procedure will be performed under the standard of care technique with the right ventricular lead at the right ventricular apex and the left ventricular lead targeting or postero-lateral area of the LV based on pre-procedure randomization.
A device implant procedure will be performed under the standard of care technique with the right ventricular lead at the right ventricular apex and the left ventricular lead targeting or antero-lateral area of the LV based on pre-procedure randomization.
Southern Arizona VA Health Care System
Tucson, Arizona, United States
RECRUITINGLexington VA Medical Center
Lexington, Kentucky, United States
RECRUITINGChange (reduction) in left ventricular end systolic volume (LVESV)
Time frame: 3 and 6 months
Change in 6 minute walk tests
Time frame: 6 weeks, 3 and 6 months
Myocardial performance as measured by myocardial performance index (MPI)
Time frame: 6 months
Papillary muscle velocity as determined by tissue doppler
Time frame: 6 months
Progression of mitral regurgitation
as measured by regurgitant volume, mitral regurgitation fraction and effective regurgitant orifice area
Time frame: 6 months
Minnesota living heart failure survey
Time frame: 6 weeks, 3 and 6 months
Chronic heart failure hospitalizations
Time frame: Monitored during study participation ~ 6 months
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