NCT02070731

DEFLECT III: A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During TAVI

A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During Transcatheter Aortic Valve Implantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Keystone Heart · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized evaluation of the TriGuard™ HDH embolic deflection device during transcatheter aortic valve implantation.

Detailed description

The TriGuard HDH device is an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries during transcatheter heart valve implantation. To assess the safety, efficacy, and performance of the TriGuard HDH embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with patients undergoing unprotected TAVI. Subjects with indications for TAVI and who meet study eligibility criteria will be randomized 1:1 to one of two treatment arms: * Intervention - TAVI with the TriGuard HDH embolic deflection device * Control - standard unprotected TAVI

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	TriGuard HDH	TAVI with the TriGuard HDH embolic deflection device

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-03-01
• Completion: 2015-04-01
• First posted: 2014-02-25
• Last updated: 2015-08-27

Locations

14 sites across 6 countries: France, Germany, Israel, Italy, Netherlands, United Kingdom