NCT01772576

Safety and Performance Study of the Reliance 4-Front Lead

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Tachycardia

Interventions

Type	Name	Description
DEVICE	Reliance 4-Front lead implantation	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.

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-06-01
• Completion: 2016-08-01
• First posted: 2013-01-21
• Last updated: 2017-07-02
• Results posted: 2017-06-02

Locations

15 sites across 11 countries: Austria, China, Denmark, France, Germany, Israel, Italy, Portugal, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated device study