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

Hasselt University

Status: Unknown

Conditions: Stroke; Aortic Valve Stenosis

Treatments: Device: Placebo - current clinical practice, no cooling; Device: targeted brain cooling (33°C) by RhinoChill device

Study type: Interventional

Funder types: Other

Identifiers

NCT01822964

OCCTAVI-II

TAVI research funding (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

targeted brain cooling

Active Comparator group

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)

Treatment:

Device: targeted brain cooling (33°C) by RhinoChill device

no use of targeted brain cooling

Placebo Comparator group

Description:

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

Treatment:

Device: Placebo - current clinical practice, no cooling