NCT01856491

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

RELIANCE 4-FRONT™ Passive 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™ Passive Fixation Defibrillation Leads.

Detailed description

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.

Conditions

• Tachycardia
• Ventricular Fibrillation
• Ventricular Flutter

Interventions

Type	Name	Description
DEVICE	RELIANCE 4-FRONT™ Passive Fixation lead implantation	Implantation of transvenous defibrillation lead with passive fixation mechanism.

Timeline

• Start date: 2013-12-16
• Primary completion: 2015-11-02
• Completion: 2017-11-13
• First posted: 2013-05-17
• Last updated: 2019-04-30
• Results posted: 2017-11-20

Locations

11 sites across 3 countries: Germany, Israel, Italy

Regulatory

• FDA-regulated device study