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

Status Completed

Clinical Trial 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.

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

Clinical Trial Details

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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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms