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. Left Ventricular Capture Management (LVCM) refers to the overall method for determining left ventricular thresholds (level of energy needed to effectively pace the tissue in the lower left chamber of the heart) by measuring, analyzing, and adjusting energy delivered from the CRT device to the pacing lead. The purpose of the Left Ventricular Capture Management Software Download Clinical Trial was to evaluate the accuracy of the Left Ventricular Capture Management (LVCM) feature to support LVCM feature approval in future cardiac resynchronization therapy with defibrillation (CRT-D) devices
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
107
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Palo Alto, California, United States
Unnamed facility
Bridgeport, Connecticut, United States
Unnamed facility
Atlantis, Florida, United States
Unnamed facility
Ormond Beach, Florida, United States
Unnamed facility
Oak Lawn, Illinois, United States
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Portland, Maine, United States
Unnamed facility
Minneapolis, Minnesota, United States
...and 8 more locations
To evaluate the accuracy of left ventricular capture management (LVCM)
To compare left ventricular capture management (LVCM) measurements to a similar measurement taken automatically when subjects are completing normal daily activities
To evaluate subject rhythm and rate immediately following an LVCM measurements
To characterize all adverse events
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.