NCT02639494

Self-Centering Guide Catheter Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a guide wire across a stenotic native aortic valve into the left ventricle.

Detailed description

A prospective, open-label, single-arm feasibility study evaluating the Self-Centering Guide Catheter. All subjects who are candidates for transcatheter aortic valve replacement (TAVR) of a native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques will be evaluated for enrollment in this study. The Self-Centering Guide Catheter is intended to facilitate delivery of a guidewire across a stenotic native aortic valve and into the left ventricle.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Self-Centering Guide Catheter

Timeline

• Start date: 2016-05-12
• Primary completion: 2016-10-06
• Completion: 2016-10-06
• First posted: 2015-12-24
• Last updated: 2018-08-29
• Results posted: 2018-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study