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Oxygenation of the Cerebrum and Cooling During TAVI - Part I

NCT01759563 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2013-01-03

No results posted yet for this study

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.

Conditions

  • TAVI
  • Targeted Brain Cooling
  • Neuroprotection

Interventions

DEVICE

nasopharyngeal targeted brain cooling

Sponsors & Collaborators

  • Hasselt University

    lead OTHER

Principal Investigators

  • Cathy De Deyne, Md, PhD · Ziekenhuis Oost-Limburg

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01759563 on ClinicalTrials.gov