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Clinical Trial Summary

The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONTâ„¢ Passive Fixation Defibrillation Leads.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01856491
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase N/A
Start date December 16, 2013
Completion date November 13, 2017

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