Aortic Valve Stenosis, Stroke
Conditions
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.
Interventions
DEVICEtargeted brain cooling (33°C) by RhinoChill device
targeted brain cooling by Rhinochill device to 33°C tympanic temperature during TAVI procedure. After valve implantation, slow rewarming until 35.5°C
DEVICEPlacebo - current clinical practice, no cooling
Sponsors
Hasselt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| composite outcome measure : General Clinical Endpoints (as referring to the Valval Academic Research Consortium (VARC) - 2 recommendations) | one year | These clinical endpoints include : all-cause mortality; myocardial infarction; stroke & TIA; bleeding complication; acute kidney injury; vascular complications; conductance disturbances and arrhythmias; other TAVI-related complications; valvular function and quality of life |
Countries
Belgium
Contacts
Primary ContactCathy S De Deyne, MD, PhD
Backup ContactJo A Dens, Md, PhD
Outcome results
None listed