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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Hasselt University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Prof Dr Cathy De Deyne, Hasselt University Identifier:
First received: March 24, 2013
Last updated: April 2, 2013
Last verified: March 2013
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.

Condition Intervention
Aortic Valve Stenosis
Device: targeted brain cooling (33°C) by RhinoChill device
Device: Placebo - current clinical practice, no cooling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Hasselt University:

Primary Outcome Measures:
  • changes in cerebral oxygen saturation during periods of rapid ventricular pacing and valve implantation [ Time Frame: 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:
  • 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 ]

Other Outcome Measures:
  • composite outcome measure : General Clinical Endpoints (as referring to the Valval Academic Research Consortium (VARC) - 2 recommendations) [ Time Frame: 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

Estimated Enrollment: 30
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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
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
Device: Placebo - current clinical practice, no cooling


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01822964

Contact: Cathy S De Deyne, MD, PhD 003289325296
Contact: Jo A Dens, Md, PhD 003289327088

Ziekenhuis Oost-Limburg Recruiting
Genk, Belgium, 3600
Contact: Cathy S De Deyne, MD, PhD    003289325296   
Contact: Jo A Dens, MD, PhD    003289327088   
Principal Investigator: Jo A Dens, MD, PhD         
Universitair Ziekenhuis Not yet recruiting
Leuven, Belgium
Contact: Christophe Dubois, MD,PhD   
Principal Investigator: Christophe Dubois, MD,PhD         
Sponsors and Collaborators
Hasselt University
Principal Investigator: Cathy S De Deyne, Md, PhD University Hasselt / Ziekenhuis Oost-Limburg Genk (Belgium)
  More Information

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

Responsible Party: Prof Dr Cathy De Deyne, Prof Dr, dept of physiology, Hasselt University Identifier: NCT01822964     History of Changes
Other Study ID Numbers: OCCTAVI-II
TAVI research funding ( Other Identifier: Hasselt University )
Study First Received: March 24, 2013
Last Updated: April 2, 2013

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction processed this record on May 22, 2017