Brief Title
Oxygenation of the Cerebrum and Cooling During Transcatheter Aortic Valve Implantation (TAVI) Procedures - Part II
Brief Summary
The aim of this study is to assess the possible neuroprotective effects of cooling (targeted cooling of the brain to 33°C) during Transcatheter Aortic Valve Implantation (TAVI) procedures. From start of anesthesia, until final valve implantation, local cooling (by the RhinoChill device) will be applied to the brain. Effect of cooling on cerebral oxygenation, by cerebral oxygen saturation monitoring (NIRS ForeSight technology) during the TAVI procedure will be continuously assessed during native valve manipulation and during final valve deployment (=primary endpoint of he study). As secondary endpoints, neuropsychological testing performed before and after TAVI procedure will assess the effects of the use of cooling during the TAVI procedure. Neuron-specific enolase (NSE) and S100-beta will be analyzed during and up to 72hrs after TAVI to compare the cerebral ischemic damage between cooled and non-cooled patients. And finally, diffusion-weighted MRI of the brain will be performed 5 days before and 5-7 days after TAVI to compare the number and total amount of cerebral ischemic insults between cooled and non-cooled patients. The hypothesis behind this study is that by local cooling of the brain during manipulation of the calcified aorta and aortic valve, the brain might be protected from cerebral ischemic insults.
Study Type
Interventional
Primary Outcome
changes in cerebral oxygen saturation during periods of rapid ventricular pacing and valve implantation
Secondary Outcome
composite outcome measure : MRI of the brain before and after TAVI; NSE before and after TAVI; S100-B before and after TAVI; neuropsychological testing before and after TAVI
Condition
Aortic Valve Stenosis
Intervention
targeted brain cooling (33°C) by RhinoChill device
Study Arms / Comparison Groups
targeted brain cooling
Description: In these 15 pts, targeted brain cooling (tympanic temperature of 33°C) will be applied during the TAVI intervention by the use of the RhinoChill device (Benechill Inc, San Diego cA)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
30
Start Date
March 2013
Completion Date
December 2014
Primary Completion Date
March 2014
Eligibility Criteria
Inclusion Criteria: - pts scheduled for transcatheter aortic valve implantation Exclusion Criteria: - pts with pacemaker already implanted - pts with recent stroke or Transient Ischemic Attacks (TIA) (6months) - pts with extreme claustrophobia for MRI brain examination
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Cathy S De Deyne, Md, PhD, 003289325296, [email protected]
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT01822964
Organization ID
OCCTAVI-II
Secondary IDs
TAVI research funding
Responsible Party
Principal Investigator
Study Sponsor
Hasselt University
Study Sponsor
Cathy S De Deyne, Md, PhD, Principal Investigator, University Hasselt / Ziekenhuis Oost-Limburg Genk (Belgium)
Verification Date
March 2013