NCT01822964

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 4, 2013

Status Verified

March 1, 2013

Enrollment Period

1 year

First QC Date

March 24, 2013

Last Update Submit

April 2, 2013

Conditions

Aortic Valve StenosisStroke

Outcome Measures

Primary Outcomes (1)

  • changes in cerebral oxygen saturation during periods of rapid ventricular pacing and valve implantation

    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 Outcomes (1)

  • 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

    one year

Other Outcomes (1)

  • composite outcome measure : General Clinical Endpoints (as referring to the Valval Academic Research Consortium (VARC) - 2 recommendations)

    one year

Study Arms (2)

targeted brain cooling

ACTIVE COMPARATOR

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

no use of targeted brain cooling

PLACEBO COMPARATOR

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

Interventions

targeted brain cooling (33°C) by RhinoChill deviceDEVICE

targeted brain cooling by Rhinochill device to 33°C tympanic temperature during TAVI procedure. After valve implantation, slow rewarming until 35.5°C

targeted brain cooling
Placebo - current clinical practice, no coolingDEVICE
no use of targeted brain cooling

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • pts scheduled for transcatheter aortic valve implantation

You may not qualify if:

  • pts with pacemaker already implanted
  • pts with recent stroke or Transient Ischemic Attacks (TIA) (6months)
  • pts with extreme claustrophobia for MRI brain examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

RECRUITING

Universitair Ziekenhuis

Leuven, Belgium

NOT YET RECRUITING

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Aortic Valve StenosisStroke

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Officials

  • Cathy S De Deyne, Md, PhD

    University Hasselt / Ziekenhuis Oost-Limburg Genk (Belgium)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathy S De Deyne, MD, PhD

CONTACT

003289325296cathy.dedeyne@ZOL.be

Jo A Dens, Md, PhD

CONTACT

003289327088jo.dens@ZOL.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr, dept of physiology

Study Record Dates

First Submitted

March 24, 2013

First Posted

April 4, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Study Completion

December 1, 2014

Last Updated

April 4, 2013

Record last verified: 2013-03

Locations

BE(2)