safety and performance study of the reliance 4-front passive fixation lead

Conditions: Tachycardia; Ventricular Fibrillation; Ventricular Flutter

Summary: the objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the reliance 4-front™ passive fixation defibrillation leads.

the reliance 4-front passive fixation 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 passive fixation defibrillation leads. a total of 167 patients (including 10 % attrition) are required to evaluate the primary endpoint. up to 10 investigational centers located in europe and israel. lead-related complication-free rate (cfr) from implant through 3 months post-implant. lead-related complications associated with the reliance 4-front passive 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 passive 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 passive 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 passive fixation pmcf study will use standard statistical methodology as specified more in detail in the protocol.

Eligibility criteria:
inclusion criteria: * willing and capable of providing informed consent * has an indication for implantation of a single or dual chamber icd or crt-d system in their respective geography * subjects planned to be implanted with the reliance 4-front passive fixation lead * willing and capable of participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol * age 18 or above, or of legal age to give informed consent specific to state and national law exclusion criteria: * known or suspected sensitivity to dexamethasone acetate (dxa) * mechanical tricuspid heart valve * subject is enrolled in any other concurrent study without prior written approval from boston scientific (bsc), with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following: * schedule of procedures for the reliance 4-front study (i.e. should not cause additional or missed visits); * reliance 4-front study outcome (i.e. involve medications that could affect the heart rate of the subject); * conduct of the reliance 4-front study per good clinical practice (gcp)/ international organization for standardization (iso) 14155:2011/ 21 cfr 812/ local regulations * currently on the active heart transplant list * documented life expectancy of less than 12 months * women of childbearing potential who are or might be pregnant at the time of study enrollment (method of assessment upon physician discretion) * currently requiring chronic dialysis

Keywords: reliance 4-front implantable cardioverter defibrillator (icd) cardiac resynchronization therapy - defibrillator (crt-d)