Clinical Research Details

Clinical Research

Strategic MAnagement to Improve CRT Using Multi-Site Pacing (SMART MSP)

Study Description

The purpose of this study is to test a device feature that may help patients respond to HF therapy from their CRT-D device. This new feature is called Left Ventricular Multi-Site Pacing (LV MSP). This feature is contained in your implanted device, but is not operational unless it is turned on by your doctor. This feature allows pacing to occur at two locations on your LV lead, instead of only one. The study will evaluate the effectiveness and confirm safety of the LV MSP feature. The BSC CRT-D devices and the LV leads are approved for commercial use in the US. There are no procedures which are experimental in this study.

Study visits will include the Enrollment Visit and a 6-month Follow-up Visit for all patients. A subset of patients will also complete a 12-month Follow-up Visit. The Enrollment Visit will occur within 21 days of the implant date of your device and leads. All study visits will include routine testing of your leads and device, in addition to study related electrical testing and data collection of your implanted device and lead system which you would not have done if you did not participate in this study. This study related electrical testing and data collection will add approximately an additional hour to each of your scheduled office visits. If you agree to participate in this study, your doctor will schedule your study follow-up visits. The follow-up visits and information collected during the conduct of the study are routinely done by your doctor. Follow-up testing of your CRT-D device and leads may be done at the same intervals as if you were not in the study. During these visits your study doctor will check your CRT-D device and leads to ensure that they are working properly and will also check to see if you have had any abnormal heart rhythms. At your doctor’s discretion, you may be asked to come in for additional follow-up visits to review your condition and confirm your device is working properly.

Open Enrollment

Contact Name: John Catanzaro
Contact Phone: (904) 244-4660
Contact Email: John.catanzaro@jax.ufl.edu

Investigators


Principal Investigator
John N. Catanzaro, M.D., FACC, FESC, FHRS
Medicine