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Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation.

NCT01237743 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2011-03-15

No results posted yet for this study

Summary

Transcatheter Aortic Valve Implantation (TAVI) using femoral access is an option for definitive treatment of aortic stenosis when open-heart surgery is considered inappropriate. By avoiding the effects of cardiopulmonary bypass on cerebral hemodynamics and microembolic load, TAVI is assumed to be beneficial regarding risk for neurological complications. We anticipated that the extensive endovascular retrograde manipulation in ascending aorta and aortic root would generate a detectable cerebral microembolic load, and thus an increase in serological markers of neuronal injury postoperatively. Our hypothesis is that there is a positive correlation between the total amount of cerebral microembolic events during the TAVI procedure and the Area under curve (AUC24hrs) for the release pattern of two markers of neuronal injury. We also wish to describe the extent and distribution of microembolisms during the TAVI procedure using Transcranial Doppler (TCD).

Conditions

  • Aortic Stenosis

Interventions

DEVICE

Transcatheter aortic valve implantation.

Transcatheter aortic valve implantation,femoral access.

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Sven Erik Ricksten, Professor · Sahlgrenska University Hospital,Thoracic Anesthesia & Intensive Care

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01237743 on ClinicalTrials.gov