Study ID: QP ExCELs
QP ExCELs: Sentus QP – extended CRT evaluation with quadripolar left ventricular leads
This study is for patients for whom a cardiac resynchronization therapy defibrillator (CRT-D) is necessary. These systems are made up of a device called a pulse generator and contain a computer that stores information about the patient’s heartbeat. This study is to test the safety, effectiveness and side effects of the investigational Biotronik Sentus QP leads models when used with the Biotronik CRT-D device.
There are two models in two lengths available, and one will be implanted in subjects' hearts. Only the QP Sentus lead is considered investigational, although it is approved for use in Europe. The CRT-D system and the other leads have already been FDA approved; it may offer cardiologists more options to find a stable position of leads during placement and gives more options for reprogramming.
This study aims to gather safety and effectiveness data on Biotronik Sentus QP leads. Results will be used to satisfy FDA requirements for pre-market submission of the Sentus over-the-wire quadripolar left ventricular leads. Models being tested include: Sentus OTW QP L-75, Sentus OTW QP L-85, Sentus OTW QP S-75 and Sentus OTW QP S-85. Study will enroll subjects with a standard CRT-D indication.
Must have been diagnosed by your physician or cardiologist with cardiac arrhythmia (heart rhythm disorder) and you are in need of a cardiac resynchronization therapy defibrillator implanted