NCT01128751

Elimination of Microemboli During Aortic Valve Replacement

ELMAR - Elimination of Microemboli During Aortic Valve Replacement. A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of Giessen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In a randomized controlled trial patients undergoing aortic valve replacement are recruited into 3 groups. Patients receive either an intra-aortic filter (Embol-X), designed to reduce solid microemboli during mechanical surgical intervention, a dynamic bubble-trap (DBT), designed to reduce gaseous microemboli from cardiopulmonary bypass (CPB), or no additional device (control-group). Cognitive functioning is assessed 3 weeks to 1 day before and 3 months (+/- 1 week) after valve replacement. Furthermore, cerebral magnetic resonance imaging (MRI) is carried 2-6 days after surgery. Primary endpoint is the cognitive outcome of the filter groups compared to the controls. Secondary endpoint is the number of acute ischemic lesions after CABG.

Conditions

• Neurocognitive Outcome After Aortic Valve Replacement

Interventions

Type	Name	Description
PROCEDURE	Embol-X intra-aortic emboli filter	Patients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery.
PROCEDURE	DBT dynamic bubble trap	Patients in this arm receive a dynamic bubble trap to reduce gaseous micro-emboli from cardiopulmonary bypass for neuroprotection during surgery
PROCEDURE	Control group	In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-12-01
• First posted: 2010-05-24
• Last updated: 2010-05-24

Locations

3 sites across 1 country: Germany