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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ 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


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 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • 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


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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01822964

Contacts
Contact: Cathy S De Deyne, MD, PhD 003289325296 cathy.dedeyne@ZOL.be
Contact: Jo A Dens, Md, PhD 003289327088 jo.dens@ZOL.be

Locations
Belgium
Ziekenhuis Oost-Limburg Recruiting
Genk, Belgium, 3600
Contact: Cathy S De Deyne, MD, PhD    003289325296    cathy.dedeyne@ZOL.be   
Contact: Jo A Dens, MD, PhD    003289327088    jo.dens@ZOL.be   
Principal Investigator: Jo A Dens, MD, PhD         
Universitair Ziekenhuis Not yet recruiting
Leuven, Belgium
Contact: Christophe Dubois, MD,PhD       christophe.dubois@uzleuven.be   
Principal Investigator: Christophe Dubois, MD,PhD         
Sponsors and Collaborators
Hasselt University
Investigators
Principal Investigator: Cathy S De Deyne, Md, PhD University Hasselt / Ziekenhuis Oost-Limburg Genk (Belgium)
  More Information

No publications provided

Responsible Party: Prof Dr Cathy De Deyne, Prof Dr, dept of physiology, Hasselt University
ClinicalTrials.gov Identifier: NCT01822964     History of Changes
Other Study ID Numbers: OCCTAVI-II, TAVI research funding
Study First Received: March 24, 2013
Last Updated: April 2, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Aortic Valve Stenosis
Stroke
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014