Aortic Valve StenosisNCT01822964
Oxygenation of the Cerebrum and Cooling During Transcatheter Aortic Valve Implantation (TAVI) Procedures - Part II
A study testing targeted brain cooling (33°C) by RhinoChill device in people with Aortic Valve Stenosis and Stroke, run by Hasselt University at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis, Stroke
- What is being tested?
- targeted brain cooling (33°C) by RhinoChill device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesBelgium
- Study dates
- Mar 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pts scheduled for transcatheter aortic valve implantation
Who cannot join
- pts with pacemaker already implanted
- pts with recent stroke or Transient Ischemic Attacks (TIA) (6months)
- pts with extreme claustrophobia for MRI brain examination
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
Ziekenhuis Oost-Limburg
Genk, 3600
Cathy S De Deyne, MD, PhD, 003289325296, cathy.dedeyne@ZOL.be
Jo A Dens, MD, PhD, 003289327088, jo.dens@ZOL.be
- Not yet recruiting
Universitair Ziekenhuis
Leuven
Christophe Dubois, MD,PhD, christophe.dubois@uzleuven.be
Christophe Dubois, MD,PhD
About this study
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
- Being tested
- targeted brain cooling (33°C) by RhinoChill device, Placebo - current clinical practice, no cooling
- Medical subject headings
- Aortic Valve Stenosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Placebo - current clinical practice, no coolingDevice
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Device: Placebo - current clinical practice, no cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr Cathy De Deyne, Hasselt University
- Investigators
- Cathy S De Deyne, Md, PhD, Principal investigator, University Hasselt / Ziekenhuis Oost-Limburg Genk (Belgium)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822964
- Sponsor's protocol ID
- OCCTAVI-II
- Other IDs
- TAVI research funding
- Status last verified
- Mar 2013
- First submitted
- 24 Mar 2013
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
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 at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygenation of the Cerebrum and Cooling During Transcatheter Aortic Valve Implantation (TAVI) Procedures - Part II
- ClinicalTrials.gov ID
- NCT01822964
- Acronym / sponsor ID
- OCCTAVI-II
- Conditions
- Aortic Valve Stenosis, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| targeted brain cooling | Active comparator | Device: targeted brain cooling (33°C) by RhinoChill deviceIn 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) |
| no use of targeted brain cooling | Placebo comparator | Device: Placebo - current clinical practice, no coolingIn 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- pts scheduled for transcatheter aortic valve implantation
Key exclusion criteria (3 listed)
- pts with pacemaker already implanted
- pts with recent stroke or Transient Ischemic Attacks (TIA) (6months)
- pts with extreme claustrophobia for MRI brain examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| targeted brain cooling (33°C) by RhinoChill devicetargeted brain cooling by Rhinochill device to 33°C tympanic temperature during TAVI procedure. After valve implantation, slow rewarming until 35.5°C | Device | targeted brain cooling |
| Placebo - current clinical practice, no cooling | Device | no use of targeted brain cooling |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
- Background1. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy S De Deyne, Md, PhD principal investigator
University Hasselt / Ziekenhuis Oost-Limburg Genk (Belgium)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing targeted brain cooling (33°C) by RhinoChill device in people with Aortic Valve Stenosis and Stroke, run by Hasselt University at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cathy S De Deyne, MD, PhD (003289325296, cathy.dedeyne@ZOL.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in cerebral oxygen saturation during periods of rapid ventricular pacing and valve implantation (time frame: during TAVI procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01822964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.