Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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RELIANCE 4-FRONT™ Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up (PMCF) Study

Conditions
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Tachycardia, Ventricular Fibrillation, Ventricular Flutter

Intervention / Treatment
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* Device: RELIANCE 4-FRONT™ Passive Fixation lead implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: RELIANCE 4-FRONT™ Passive Fixation<br>Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead | Device: RELIANCE 4-FRONT™ Passive Fixation lead implantation<br>* Implantation of transvenous defibrillation lead with passive fixation mechanism.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication Free Rate | Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant. | 3-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication Free Rate | Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant. | 3 months through 15 months post implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RELIANCE 4-FRONT, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy - Defibrillator (CRT-D)