Oxygenation of the Cerebrum and Cooling During Transcatheter Aortic Valve Implantation (TAVI) Procedures - Part II

Not Applicable

• Conditions: Aortic Valve Stenosis; Stroke
• Interventions: Device: targeted brain cooling (33°C) by RhinoChill device; Device: Placebo - current clinical practice, no cooling

• Registration Number: NCT01822964
• Lead Sponsor: Hasselt University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-03
• Study Start: 2013-03
• Study First Submitted: 2013-03-24
• Study First Submitted QC: 2013-04-02
• Last Update Submitted: 2013-04-02
• Study First Posted: 2013-04-04
• Last Update Posted: 2013-04-04
• Primary Completion: 2014-03
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
targeted brain cooling	targeted brain cooling (33°C) by RhinoChill device	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)
no use of targeted brain cooling	Placebo - current clinical practice, no cooling	In these 15 pts, no cooling techniques will be applied and current clinical practice as to maintenance of normothermia will be followed during these TAVI interventions

Primary Outcome Measures

Name	Time	Method
changes in cerebral oxygen saturation during periods of rapid ventricular pacing and valve implantation	during TAVI procedure	changes in cerebral oxygen saturation during periods of rapid ventricular pacing (RVP) and valve implantation; changes in cerebral oxygen saturation compared to baseline values (of 10min) before periods of RVP (Area Under the Curve will be analysed and compared between cooled end non-cooled patients

Secondary Outcome Measures

Name	Time	Method
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	one year

Trial Locations

Locations (2)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

Universitair Ziekenhuis; 🇧🇪 Leuven, Belgium