The objective of the LSS of 4-SITE Study is to prospectively determine the chronic complication-free rate of the 4-SITE Lead/Header System in order to verify its long-term functional integrity and to meet the FDA’s requirements for a post approval clinical study.
The primary purpose of this study is to evaluate, document and report on the appropriate clinical performance, the long-term reliability and the functional integrity of the 4-SITE Lead/Header System. This 4-SITE Lead/Header System consists of a 4-SITE ENDOTAK® RELIANCE defibrillation lead connected to a 4-SITE Header (which is the only PG component under study) of a single or dual chamber (VR and DR) implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy ICD (CRT-D) pulse generator. Additionally, system-related diagnostic information and implant data will be collected during the conduct of this study.
Principal Investigator: Frederick Han