COOL-ARREST Pilot Study to Assess Intravascular Temperature Management (IVTM) in the Treatment of Cardiac Arrest

Completed

• Conditions: Out of Hospital Cardiac Arrest
• Interventions: Device: ZOLL Intravascular Temperature Management System (IVTM)

• 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

Study Timeline

• Study First Submitted: 2013-02-04
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-26
• Study Start: 2014-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-04
• Last Update Submitted: 2018-06-25
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IVTM system, therapeutic hypothermia	ZOLL Intravascular Temperature Management System (IVTM)	Induced therapeutic hypothermia post cardiac arrest

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

Chattanooga Center for Neurologic Research; 🇺🇸 Chattanooga, Tennessee, United States

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Greenville Hospital System; 🇺🇸 Greenville, South Carolina, United States

Palmetto Health Clinical Trials Department; 🇺🇸 Columbia, South Carolina, United States

Wayne State University / Detriot Medical Center; 🇺🇸 Detroit, Michigan, United States

Minneapolis Heart Institute Foundation; 🇺🇸 Minneapolis, Minnesota, United States