NCT02389894

Neuroprotection in Patients Undergoing Aortic Valve Replacement

Neuroprotection In Patients Undergoing Aortic Valve Replacement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 383 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).

Detailed description

This is a multicenter randomized trial in which patients diagnosed with calcific aortic stenosis (AS) with planned AVR will be randomized to 1) the treatment arm of the Edwards Life Science filter and cannula or the filter as a stand alone with any cannula or 2) to the treatment arm of the CardioGard cannula versus 3) standard care in a 1:1:1 ratio.

Conditions

• Aortic Stenosis
• Brain Infarction
• Cerebrovascular Accident
• Stroke

Interventions

Type	Name	Description
DEVICE	Embol-X Embolic Protection Device	per the manufacturer's instructions for use (IFU).
DEVICE	CardioGard Cannula	CardioGard Cannula, per the manufacturer's instructions for use (IFU).

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-03-17
• Last updated: 2019-04-29
• Results posted: 2019-04-29

Locations

18 sites across 2 countries: United States, Canada