Oxygenation of the Cerebrum and Cooling During TAVI - Part I
OCCTAVI-I
Safety and Feasibility Study of Nasopharyngeal Cooling (RhinoChill Device) During Transcutaneous Aortic Valve Implantation
2 other identifiers
interventional
6
1 country
1
Brief Summary
Assessment of safety and feasibility of using a nasopharyngeal cooling technique to provide targeted brain cooling during percutaneous implantation of aortic valves. Was it possible to obtain brain temperatures below 34° within a reasonable time interval (max of 1hr) without delaying the procedure of valve implantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2012
Shorter than P25 for phase_3
1 active site
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
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 27, 2012
CompletedFirst Posted
Study publicly available on registry
January 3, 2013
CompletedJanuary 3, 2013
January 1, 2013
5 months
December 27, 2012
January 2, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Primary outcome is the brain temperature obtained after initiation of nasopharyngeal cooling. Safety-outcome includes local or systemic side-effects of used cooling technique.
By the use of nasopharyngeal cooling, brain temperature will be decreased. Time to brain temperature below 34° will be recorded. Local side effects could occur due to the use of this specific nasopharyngeal cooling technique and systemic side effects (especially cardiovascular) could occur due to the initiation of hypothermia
Day1: start of cooling until brain temperature above 35.5°C
Secondary Outcomes (1)
changes in cerebral oxygenation (NIRS Fore-Sight technology) induced by targeted brain cooling
Day 1: start of cooling until brain temperature above 35.5°C
Other Outcomes (1)
Influence of targeted brain cooling on systemic core temperature
Day 1: start of cooling until brain temperature above 35.5°C
Study Arms (1)
single arm study
OTHERInterventions
Eligibility Criteria
You may qualify if:
- pts eligible for TAVI interventions
You may not qualify if:
- urgent intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
Related Publications (1)
Castren M, Nordberg P, Svensson L, Taccone F, Vincent JL, Desruelles D, Eichwede F, Mols P, Schwab T, Vergnion M, Storm C, Pesenti A, Pachl J, Guerisse F, Elste T, Roessler M, Fritz H, Durnez P, Busch HJ, Inderbitzen B, Barbut D. Intra-arrest transnasal evaporative cooling: a randomized, prehospital, multicenter study (PRINCE: Pre-ROSC IntraNasal Cooling Effectiveness). Circulation. 2010 Aug 17;122(7):729-36. doi: 10.1161/CIRCULATIONAHA.109.931691. Epub 2010 Aug 2.
PMID: 20679548BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Cathy De Deyne, Md, PhD
Ziekenhuis Oost-Limburg
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof Dr Jo Dens
Study Record Dates
First Submitted
December 27, 2012
First Posted
January 3, 2013
Study Start
July 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
January 3, 2013
Record last verified: 2013-01