NCT02073851

DEFLECT II: A Study to Evaluate the Safety and Performance of the TriGuard™HDH in Patients Undergoing TAVR

A Prospective, Single Arm Feasibility Pilot Study to Evaluate the Safety and Performance of the TriGuard™HDH Embolic Deflection Device in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Keystone Heart · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pilot study enrolling up to 12 patients at a single investigational site in the Netherlands. Patients for TAVR will be enrolled to receive the Embolic Deflection Device throughout the duration of the TAVR procedure.

Detailed description

Prospective, single center, single arm pilot study enrolling up to 12 patients at a single investigational site in the netherlands. Patients meeting eligibility criteria for TAVR and none of the exclusion criteria will be enrolled to receive the Embolic Deflection Device throughout the duration of the TAVR procedure.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	TriGuard™HDH	TriGuard™HDH Embolic Deflection Device in patients undergoing Transcatheter Aortic Valve Replacement (TAVR)

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2014-02-27
• Last updated: 2015-08-27

Locations

1 site across 1 country: Netherlands