CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,244 enrolled
Drug / intervention
ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation leaddevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02071173
NCT02071173N/ACompleted
CompareCT.gov

Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads: NAVIGATE X4

Boston Scientific Corporation·interventional·Posted Feb 25, 2014·Updated Jan 7, 2021

In Brief

A clinical study evaluating ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead for Cardiac Resynchronization Therapy. Completed, enrolled 2,244 participants across 96 sites.

Detailed Summary

The objective of the NAVIGATE X4 Clinical Study is to gather data to establish the safety, performance and effectiveness of the ACUITY™ X4 quadripolar coronary venous leads and the RELIANCE 4-FRONT™ ventricular defibrillation leads to satisfy FDA requirements for pre-market submission. Additionally, data from this study will be used to support post-market approval requirements for the ACUITY X4 and RELIANCE 4-FRONT leads.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Resynchronization Therapy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 25, 2014
Enrollment StartApr 14, 2014
Primary CompletionApr 19, 2017
Study CompletionOct 6, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 12.4 years ago

Interventions

ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation leaddevice

The ACUITY X4 leads are intended for chronic left ventricular pacing and sensing. The leads have 3 tip configuration designs (straight tip, short tip spiral, and long tip spiral), which is intended to provide choices for patients with different anatomies. The RELIANCE 4-FRONT leads are designed for right-side heart applications within the ventricle, atrium, and superior vena cava. It is intended for permanent sensing, pacing, and defibrillation when used with a compatible implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D). Subjects were allowed to receive both the ACUITY X4 and RELIANCE 4-FRONT lead.