The RELIANCE 4-FRONT Defibrillation Lead Post Market Clinical Follow-Up Study is a prospective, non-randomized, multi-center, single-group, post market clinical study to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT active fixation defibrillation leads.~A total of 167 patients (including 10 % attrition) are required to evaluate the Primary Endpoint.~Up to 20 Investigational centers located in Europe and Asia Pacific. Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.~Lead-related complications associated with the RELIANCE 4-FRONT active fixation lead will count toward this endpoint.~Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.~Lead-related complications associated with the RELIANCE 4-FRONT active fixation lead will count toward this endpoint.~Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant~Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant~Sensed Amplitude at 3 Months Post-Implant~Pacing Impedance at 3 Months Post-Implant All endpoints will be assessed for the RELIANCE 4-FRONT active fixation lead.~Clinic visits will occur at:~Enrollment Visit (no later than 30 days prior to implant procedure)~Implant Procedure (Day 0; all future follow ups based on this date)~Pre-Discharge Clinic Visit (3 - 72 hours post-implant)~One Month Clinic Visit (30±7 days)~3 Month Clinic Visit (91 ± 21 days)~6 Month Clinic Visit (180 ± 30 days)~12 Month Clinic Visit (365 ± 45 days)~18 Month Clinic Visit (545± 45 days)~24 Month Clinic Visit (730 ± 45 days) The study will be considered completed after all subjects have completed the 24 Month follow-up and study completion is anticipated in 2015. Primary endpoint completion is anticipated after all subjects have completed the 3 Month follow-up visit. All study required visits will be completed during clinic visits.~Hypotheses testing in the RELIANCE 4-FRONT PMCF Study will use standard statistical methodology as specified more in detail in the protocol.
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Active Fixation Defibrillation Leads.