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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Hasselt University
Sponsor:
Information provided by (Responsible Party):
Prof Dr Cathy De Deyne, Hasselt University
ClinicalTrials.gov Identifier:
NCT01822964
First received: March 24, 2013
Last updated: April 2, 2013
Last verified: March 2013

March 24, 2013
April 2, 2013
March 2013
March 2014   (final data collection date for primary outcome measure)
changes in cerebral oxygen saturation during periods of rapid ventricular pacing and valve implantation [ Time Frame: during TAVI procedure ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01822964 on ClinicalTrials.gov Archive Site
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 [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
composite outcome measure : General Clinical Endpoints (as referring to the Valval Academic Research Consortium (VARC) - 2 recommendations) [ Time Frame: one year ] [ Designated as safety issue: Yes ]
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
Same as current
 
Oxygenation of the Cerebrum and Cooling During Transcatheter Aortic Valve Implantation (TAVI) Procedures - Part II
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Aortic Valve Stenosis
  • Stroke
  • Device: targeted 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
  • Device: Placebo - current clinical practice, no cooling
  • Active Comparator: targeted brain cooling
    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)
    Intervention: Device: targeted brain cooling (33°C) by RhinoChill device
  • Placebo Comparator: no use of targeted brain 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
    Intervention: Device: Placebo - current clinical practice, no cooling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Cathy S De Deyne, MD, PhD 003289325296 cathy.dedeyne@ZOL.be
Contact: Jo A Dens, Md, PhD 003289327088 jo.dens@ZOL.be
Belgium
 
NCT01822964
OCCTAVI-II, TAVI research funding
Yes
Prof Dr Cathy De Deyne, Hasselt University
Hasselt University
Not Provided
Principal Investigator: Cathy S De Deyne, Md, PhD University Hasselt / Ziekenhuis Oost-Limburg Genk (Belgium)
Hasselt University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP