Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TAVI research funding | Other Identifier | Hasselt University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| targeted brain cooling (33°C) by RhinoChill device | Device | targeted brain cooling by Rhinochill device to 33°C tympanic temperature during TAVI procedure. After valve implantation, slow rewarming until 35.5°C |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | 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 | one year |
| Measure | Description | Time Frame |
|---|---|---|
| composite outcome measure : General Clinical Endpoints (as referring to the Valval Academic Research Consortium (VARC) - 2 recommendations) | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cathy S De Deyne, MD, PhD | Contact | 003289325296 | cathy.dedeyne@ZOL.be | |
| Jo A Dens, Md, PhD | Contact | 003289327088 | jo.dens@ZOL.be |
| Name | Affiliation | Role |
|---|---|---|
| Cathy S De Deyne, Md, PhD | University Hasselt / Ziekenhuis Oost-Limburg Genk (Belgium) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Recruiting | Genk | 3600 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo - current clinical practice, no cooling | Device |
|
| one year |
| Universitair Ziekenhuis | Not yet recruiting | Leuven | Belgium |
|
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided