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.
Subject is medically indicated for implantation of an ICD/CRT-D device system in their respective geography; and
Has been or will be implanted with the 4-SITE Lead; and
Has been or will be implanted with a BSC commercially available 4-SITE compatible pulse generator; and
Plans to remain in the long-term care of his/her enrolling Investigator for the full five (5) year follow-up visit schedule; and
Is willing and capable (or appropriate legal representative is willing and capable) of authorizing access to and use of health information as required by an institution’s Institutional Review Board (IRB), Research ethics Board (REB) or Ethics Committee (EC); and
Is willing and capable (or appropriate legal representative is willing and capable) of providing authorization/consent for participation in the study.
More than 14 calendar days have passed since device system implant; or
For subjects enrolled within 14 calendar days post implant, they are excluded if any of the required implant data listed below is missing; or
Right ventricle (RV) lead and pulse generator (PG) date of implant;
RV lead and PG model and serial numbers;
RV lead implant attempts/repositioning (whether more than one lead or lead position was attempted to achieve a successful lead implant);
RV lead electrical measurements for final lead configuration (i.e., sensing, pacing threshold and impedance); or
Documented assessment of adverse event status since implant.
Subject is unable or unwilling to comply with the study protocol requirements; or
Subject is under the legal age for signing study consent in accordance with state or national law.