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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claas P. Naehle, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00883285
First received: April 16, 2009
Last updated: January 31, 2014
Last verified: January 2014
  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

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

Resource links provided by NLM:


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 ]

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)
Groups/Cohorts
1
conventional aortic valve replacement
2
transfemoral aortic valve replacement
3
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided by University Hospital, Bonn

Additional 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
Study First Received: April 16, 2009
Last Updated: January 31, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Intracranial Embolism
Embolism
Stroke
Cerebral Infarction
Heart Defects, Congenital
Heart Valve Diseases
Intracranial Embolism and Thrombosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Embolism and Thrombosis
Thrombosis
Brain Infarction
Brain Ischemia
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 31, 2014