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

NCT ID: NCT01822964

Last Updated: 2013-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-12-31

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.

Conditions

Aortic Valve Stenosis; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

targeted brain cooling (33°C) by RhinoChill device

Intervention Type: DEVICE

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

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

Group Type: PLACEBO_COMPARATOR

Placebo - current clinical practice, no cooling

Intervention Type: DEVICE

Interventions

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

Intervention Type: DEVICE

Placebo - current clinical practice, no cooling

Intervention Type: DEVICE

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Prof Dr Cathy De Deyne

Prof Dr, dept of physiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cathy S De Deyne, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hasselt / Ziekenhuis Oost-Limburg Genk (Belgium)

Locations

Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status: RECRUITING

Universitair Ziekenhuis

Leuven, , Belgium

Site Status: NOT_YET_RECRUITING

Countries

Belgium

Central Contacts

Cathy S De Deyne, MD, PhD

Role: CONTACT

cathy.dedeyne@ZOL.be

003289325296

Jo A Dens, Md, PhD

Role: CONTACT

jo.dens@ZOL.be

003289327088

Facility Contacts

Cathy S De Deyne, MD, PhD

Role: primary

cathy.dedeyne@ZOL.be

003289325296

Jo A Dens, MD, PhD

Role: backup

jo.dens@ZOL.be

003289327088

Christophe Dubois, MD,PhD

Role: primary

christophe.dubois@uzleuven.be

References

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

Reference Type: BACKGROUND

Other Identifiers

TAVI research funding

Identifier Type: OTHER

Identifier Source: secondary_id

OCCTAVI-II

Identifier Type: -

Identifier Source: org_study_id