The CardioKinetix Ventricular Partitioning Device (VPD) is intended to isolate the malfunctioning portion of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease. By isolating the malfunctioning portion of the left ventricle, it is hypothesized that the left ventricle will pump more effectively.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Percutaneous introduction using standard catheterization techniques of the VPD Implant.
Washington Hospital Center
Washington D.C., District of Columbia, United States
Northwestern University Medical Center
Chicago, Illinois, United States
Mission Hospitals
Asheville, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Assessment of safety defined as the successful delivery and deployment of the VPD Implant through 6 month follow up without the occurrence of Major Adverse Cardiac Events (MACE) related to the investigational device.
Time frame: 6 months
Preliminary Effectiveness Measurements at 6 months - Change in LV volume indices (LVESVI, LVEDVI, EF) - Change in 6 minute walk and VO2 max - Cardiovascular mortality and morbidity inclusive of hospitalization for HF, MI and stroke
Time frame: 12 months
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Geisinger Medical Center
Danville, Pennsylvania, United States
Texas Heart Institute
Houston, Texas, United States
Dedinje Cardiovascular Institute
Belgrade, Serbia