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

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ClinicalTrials.gov Identifier: NCT00883285
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : February 3, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Cerebral Stroke Aortic Valve Disease

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.

Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
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
Study Start Date : April 2009
Primary Completion Date : December 2013
Study Completion Date : December 2013
Groups and Cohorts

Group/Cohort
1
conventional aortic valve replacement
2
transfemoral aortic valve replacement
3
transapical aortic valve replacement


Outcome Measures

Primary Outcome Measures :
  1. Silent cerebral embolism [ Time Frame: 48 hours ]

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

Eligibility Criteria

Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • aortic valve replacement

Exclusion Criteria:

  • contraindication to undergo MRI
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883285


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Claas P. Naehle, Assistant Professor of Radiology, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT00883285     History of Changes
Other Study ID Numbers: 255/08
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: February 3, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Embolism
Stroke
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