A multicenter prospective single arm interventional trial in hospitals where therapeutic hypothermia is standard practice. This trial will enroll 50 subjects to evaluate the ability of the ZOLL Intravascular Temperature Management (IVTM) System to induce, maintain, and reverse mild therapeutic hypothermia and maintain normothermia post cardiac arrest.
Study Type
OBSERVATIONAL
Enrollment
50
Induced therapeutic hypothermia post cardiac arrest.
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Wayne State University / Detriot Medical Center
Detroit, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Proportion of subjects in which IVTM can therapeutically cool patients as a measure of Performance
Time frame: Day 1
Ability to Enroll Subjects, Proportion of those Enrolled that Complete the Study Protocol and Time to complete Enrollment of 50 Subjects Defined as Retention
Time frame: Up to 90 days
Incident Adverse Events Defined as Safety
Time frame: Up to 90 days
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Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Palmetto Health Clinical Trials Department
Columbia, South Carolina, United States
Greenville Hospital System
Greenville, South Carolina, United States
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States