COOL-ARREST Pilot Study to Assess Intravascular Temperature Management (IVTM) in the Treatment of Cardiac Arrest
- Conditions
- Out of Hospital Cardiac Arrest
- Registration Number
- NCT01818388
- Lead Sponsor
- ZOLL Circulation, Inc., USA
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects in which IVTM can therapeutically cool patients as a measure of Performance Day 1
- Secondary Outcome Measures
Name Time Method Incident Adverse Events Defined as Safety Up to 90 days Ability to Enroll Subjects, Proportion of those Enrolled that Complete the Study Protocol and Time to complete Enrollment of 50 Subjects Defined as Retention Up to 90 days
Trial Locations
- Locations (9)
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
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
The Hospital of Central Connecticut🇺🇸New Britain, Connecticut, United States