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

This study is currently recruiting participants.

Verified by University Hospital, Bonn, April 2009

First Received: April 16, 2009 No Changes Posted

Sponsored by:	University Hospital, Bonn
Information provided by:	University Hospital, Bonn
ClinicalTrials.gov Identifier:	NCT00883285

Purpose

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.

Condition
Cerebral Stroke Aortic Valve Disease

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-Invasive Transfemoral Aortic Valve Replacement

Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:

Silent cerebral embolism [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Apparent cerebral embolism [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	April 2009

Groups/Cohorts
1 conventional aortic valve replacement
2 transfemoral aortic valve replacement
3 transapikal aortic valve replacement

Detailed Description:

Patients undergoing aortic valve repair (AVR) are included prospectively into the study. AVR techniques include the conventional technique, the transfemoral and the transapikal 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients with aortic valve disease

Criteria

Inclusion Criteria:

aortic valve replacement

Exclusion Criteria:

contraindication to undergo MRI

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883285

Contacts

Contact: Claas P Naehle, MD	+49-228-287 ext 11123	cp@naehle.net
Contact: Daniel Thomas, MD	+49-228-287 ext 11122	daniel.thomas@ukb.uni-bonn.de

Locations

Germany, NRW
University of Bonn	Recruiting
Bonn, NRW, Germany, 53105
Contact: Claas P Naehle, MD +49-228-287 ext 11123 cp@naehle.net

Sponsors and Collaborators

University Hospital, Bonn

More Information

No publications provided

Responsible Party:	University of Bonn, Dept. of Radiology ( Dr. Claas P. Naehle, MD )
Study ID Numbers:	255/08
Study First Received:	April 16, 2009
Last Updated:	April 16, 2009
ClinicalTrials.gov Identifier:	NCT00883285 History of Changes
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Intracranial Embolism
Brain Diseases
Cerebrovascular Disorders

Intracranial Embolism and Thrombosis
Thrombosis
Thromboembolism
Embolism and Thrombosis
Embolism
Brain Ischemia
Brain Infarction
Infarction

Additional relevant MeSH terms:

Cerebral Infarction
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Intracranial Embolism
Brain Diseases
Cerebrovascular Disorders

Intracranial Embolism and Thrombosis
Thromboembolism
Thrombosis
Embolism and Thrombosis
Brain Ischemia
Cardiovascular Diseases
Brain Infarction

ClinicalTrials.gov processed this record on May 06, 2009