Cardiac Resynchronization Therapy Study

Currently, most patient who receive a cardiac resynchronization therapy (CRT) device) will have their device programmed by the standard of care method in the hospital. This might be done with the use of an echocardiogram (echo) or an electrocardiogram (ECG). The programming may also be set and left at the standard settings of the device. In this research study, the researchers will investigate the benefit of the aCRT feature compared to the other methods. The aCRT feature detects patterns in the heart’s contractions and then automatically adjusts the programming of the CRT device to provide the best CRT for the patient without using the echocardiogram or electrocardiogram. The CRT system used in this study includes the Medtronic Viva XT CRT-D or CRT-P devices or any future approved Medtronic CRT-D or CRT-P devices that contain the aCRT feature, and any left ventricular (LV), right atrial (RA) and right ventricular (RV) leads available to the public. Patients who choose to take part will have the CRT system implanted into their body during a surgery (implantation will occur no more than 30 days after signing the consent). The device is a small oval-shaped device that holds the battery and circuitry. There are also three insulated wires that carry the electrical energy from the study device to the patient’s heart. The device and leads help the two sides of the patient’s heart beat together to improve the heart’s ability to pump blood to the rest of the body. The study doctor/staff will use a computer called a programmer to “talk” to the CRT system. The programmer has software that allows it to talk to the study system by using radio signals to receive and transfer information. The programmer stays at the study doctor’s office to use during the participant’s study visits. Within 7 days of the implant, the participant will be randomly assigned to either the treatment group or the control group. Those assigned to the treatment group will have the aCRT feature turned on in their device for the duration of the study. Those assigned to the control group will not have the aCRT feature turned on in their device. Follow-up visits will take place at 3 months, 6 months, and then every 6 months until the study closes. If the participant leaves the study before the study closes, they will be asked to have a final exit visit.

In addition, the study doctor may sign the participant up in the Medtronic CareLink system, which is available to the public. It allows the participant’s device to transmit information stored in the device over a standard analog telephone line to the study doctor’s office from the participant’s home, office, or any other location in the United States. After the CareLink monitor has recorded the information from the device, it “talks” with a special computer and sends the information to a secure Medtronic server where it is then sent to an internet site on the CareLink network. The study doctor or study nurse can view the information from the CRT device on a computer by using a secure password. The information from the CareLink monitor is the same information the study doctor would get from the device during a regular office visit. For this study, CareLink transmissions are not required.   However, if the CareLink transmissions are done, the information gathered from the CareLink system will be added to the health information collected for the study.