Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement

Aortic Valve Disease Clinical Trial

Official title:

Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883285
• Other study ID #: 255/08
• Status: Completed
• Phase: N/A
• First received: April 16, 2009
• Last updated: January 31, 2014
• Start date: April 2009
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to compare the incidence of silent and apparent cerebral embolism between conventional and minimal-invasive transfemoral aortic valve repair.

Description:

Patients undergoing aortic valve repair (AVR) are included prospectively into the study. AVR techniques include the conventional technique, the transfemoral and the transapical approach. Before the intervention CT of the chest is performed preoperatively to assess the degree of aortic and aortic valve calcification. Patients undergo MRI of the brain, including diffusion weighted imaging (DWI) and neurological assessment (NIHSS score) within 48 h before and after the procedure to assess occurrence of cerebral embolism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aortic valve replacement

Exclusion Criteria:

• contraindication to undergo MRI

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Valve Disease
• Cerebral Stroke
• Heart Defects, Congenital
• Heart Valve Diseases
• Stroke

Locations

Country	Name	City	State
Germany	University of Bonn	Bonn	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Silent cerebral embolism		48 hours	Yes
Secondary	Apparent cerebral embolism		48 hours	Yes