Safety and Performance Study of the Reliance 4-Front Lead

Boston Scientific Corporation167 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

167

Conditions

Tachycardia

Interventions

Reliance 4-Front lead implantationDEVICE

The patients selected for participation should be from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Active 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

Locations (15)

Landesklinikum St. Poelten

Sankt Pölten, Austria

Queen Mary Hospital

Hong Kong, China

Aarhus University Hospitals

Aarhus, Denmark

Outcomes

Primary Outcomes

Complication Free Rate

Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.

Time frame: 3-months follow-up

Secondary Outcomes

Complication Free Rate

Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.

Time frame: 3 months through 15 months post implant

Data from ClinicalTrials.gov

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