Clinical trial NCT01822964: Oxygenation of the Cerebrum and Cooling During Transcatheter Aortic Valve Implantation (TAVI) Procedures - Part II
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Valve Stenosis
Stroke
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: changes in cerebral oxygen saturation during periods of rapid ventricular pacing and valve implantation
timeFrame: during TAVI procedure
Secondary outcomes:
measure: 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
timeFrame: one year
Other outcomes:
measure: composite outcome measure : General Clinical Endpoints (as referring to the Valval Academic Research Consortium (VARC) - 2 recommendations)
timeFrame: one year
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis
Study officials:
affiliation: University Hasselt / Ziekenhuis Oost-Limburg Genk (Belgium)
name: Cathy S De Deyne, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1. Vahanian A, Alfieri O, Al-Attar N, Antunes M, Bax J, Cornier B, Cribier A, De Jaegere P, Fournial G, Kappetein AP et al. Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European association of cardio-thoracic surgery (EACTS- and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eurointervention 2008;4:193-199 2. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Eng J Med 2010;363:1597-1607 3. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tizcu EM, Webb JG, Fontana GP, Makkar RR et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Eng J Med 2011;364:2187-2198 4. Grube E, Naber C, Abizaid A, Sousa E, Mendiz O, Lemos P et al. Feasibility of transcatheter aortic valve implantation withoutn balloon pre-dilatation. JACC Cardiovasc Interv 2011;4:751-757 5. Bagur R, Rodes-Cabau J, Doyle D, De Larochelière R, Villeneuve J, Bertrand OF et al. Transcatheter aortic valve implantation with