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

This study has been completed.
Information provided by (Responsible Party):
Claas P. Naehle, University Hospital, Bonn Identifier:
First received: April 16, 2009
Last updated: January 31, 2014
Last verified: January 2014
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.

Cerebral Stroke
Aortic Valve Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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 ]

Secondary Outcome Measures:
  • Apparent cerebral embolism [ Time Frame: 48 hours ]

Estimated Enrollment: 60
Study Start Date: April 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
conventional aortic valve replacement
transfemoral aortic valve replacement
transapical 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 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with aortic valve disease

Inclusion Criteria:

  • aortic valve replacement

Exclusion Criteria:

  • contraindication to undergo MRI
  Contacts and Locations
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Please refer to this study by its identifier: NCT00883285

University of Bonn
Bonn, NRW, Germany, 53105
Sponsors and Collaborators
University Hospital, Bonn
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Claas P. Naehle, Assistant Professor of Radiology, University Hospital, Bonn Identifier: NCT00883285     History of Changes
Other Study ID Numbers: 255/08
Study First Received: April 16, 2009
Last Updated: January 31, 2014

Additional relevant MeSH terms:
Intracranial Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Embolism and Thrombosis
Thromboembolism processed this record on May 25, 2017