NCT02071173

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,244 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Resynchronization Therapy

Interventions

Type	Name	Description
DEVICE	ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead	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.

Timeline

• Start date: 2014-04-14
• Primary completion: 2017-04-19
• Completion: 2020-10-06
• First posted: 2014-02-25
• Last updated: 2021-01-07
• Results posted: 2020-10-30

Locations

96 sites across 1 country: United States