NCT03130491

European Study Evaluating the EMBLOK Embolic Protection System During TAVR

European Study Evaluating the EMBLOK Cerebral Embolic Protection System During Transcatheter Aortic Valve Replacement (TAVR)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Emblok, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate the performance and the treatment effect of the use of the Emblok embolic protection system use during transcatheter aortic valve replacement with respect to procedure-related cerebral embolic burden as determined by DW-MRI.

Detailed description

The enrollment of up to thirty subjects with severe native aortic valve stenosis who meet clinically approved indications for transcatheter aortic valve replacement. The primary objective evaluates performance and treatment effect of the use of the EMBLOK. A secondary objective of this study is to analyze the safety profile and the type of captured debris from the Emblok filter after TAVR. Due to the small sample size, the study is not powered to detect a reduction in actual stroke rates. However, the potential risk of stroke will be assessed based on neurological evaluations pre and post procedure. In addition, silent ischemic damage and cerebral embolic burden will be assessed using DW MRI studies.

Conditions

• Aortic Valve Disease

Interventions

Type	Name	Description
PROCEDURE	Transcatheter Aortic Valve Replacement (TAVR)	placement of a filter to capture and remove embolic material from entering the cerebral vascular circulation during aortic valve replacement
DEVICE	EMBLOK filter	Embolic Filter Protection System During TAVR

Timeline

• Start date: 2017-03-08
• Primary completion: 2021-11-01
• Completion: 2022-01-28
• First posted: 2017-04-26
• Last updated: 2024-03-05

Locations

2 sites across 1 country: Italy