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

April 2, 2013 updated by: Prof Dr Cathy De Deyne, Hasselt University
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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jo A Dens, MD, PhD
  • Phone Number: 003289327088
  • Email: jo.dens@ZOL.be

Study Locations

      • Genk, Belgium, 3600
        • Recruiting
        • Ziekenhuis Oost-Limburg
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jo A Dens, MD, PhD
      • Leuven, Belgium
        • Not yet recruiting
        • Universitair Ziekenhuis
        • Contact:
        • Principal Investigator:
          • Christophe Dubois, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during TAVI procedure

Secondary Outcome Measures

Outcome 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
Time Frame: one year
one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Cathy S De Deyne, Md, PhD, University Hasselt / Ziekenhuis Oost-Limburg Genk (Belgium)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ANTICIPATED)

March 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

March 24, 2013

First Submitted That Met QC Criteria

April 2, 2013

First Posted (ESTIMATE)

April 4, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 2, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • OCCTAVI-II
  • TAVI research funding (OTHER: Hasselt University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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