IRB Protocol #: 1405015148

Overview: The purpose of the study is to test an algorithm or programming of the CRT system. It is a randomized study so you may be assigned (“randomized”) to one of two groups. You will either be in the “treatment” group which means your device will have the new aCRT feature turned on or be in the “control” group which means your CRT device will be programmed by whatever other method your study doctor chooses. A Cardiac Resynchronization Therapy (CRT) device system is a treatment for heart failure. It is an electronic medical device that is implanted in the body to provide electrical pacing to both of the lower chambers of the heart (ventricles), so they will beat at exactly the same time, or almost exactly, which can help your heart to pump blood to the body more efficiently. This kind of device includes a small computer which determines the pacing of the ventricles, as well as insulated wires or “leads” to connect the pacing device to the heart.

When a patient receives a CRT system, the timing of the pacing must be established. This is called “programming” the device. Currently, patients who receive a CRT system may have the device programmed with the standard settings installed by the manufacturer, or the settings may be adjusted by a cardiologist with the help of an echocardiogram (echo) or an electrocardiogram (ECG). The Medtronic devices being used in this study possess a feature called AdaptivCRT or aCRT. This feature detects patterns in the heart’s contractions and automatically adjusts the programming of the CRT device without using an echo or ECG. This feature has been approved for use by the Food and Drug Administration (FDA). The purpose of this study is to investigate whether aCRT provides better health outcomes than any of the other programming options available to the cardiologist for treatment of a person with a heart condition similar to yours.

In order to answer this question, half of the subjects enrolled in this study will receive a CRT device that is programmed by the aCRT feature. The other half of the subjects will receive a CRT device that is programmed by whatever other method the cardiologist would use, according to their best medical judgment, for a person who received this device but was not enrolled in the study. It is important to understand that, currently, cardiologists are not required to use the aCRT feature, or any other single method, to program CRT devices, because it is not known with certainty whether any one method is better than the others.

This trial is funded by Medtronic.

To be eligible, patients must:

• Be greater than 18
• Have been diagnosed with Left Bundle Branch Block (LBBB)

Patients cannot participate if they have:

• Have been diagnosed with permanent atrial arrhythmias
• Have received  a mechanical tricuspid heart valve

The AdaptResponse Study