NCT01818388

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

A Multicenter, Prospective, Single Arm Observational Trial to Assess Intravascular Temperature Management (IVTM) in the Treatment of Cardiac Arrest

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: ZOLL Circulation, Inc., USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Out of Hospital Cardiac Arrest

Interventions

Type	Name	Description
DEVICE	ZOLL Intravascular Temperature Management System (IVTM)	Induced therapeutic hypothermia post cardiac arrest.

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2013-03-26
• Last updated: 2018-06-26

Locations

9 sites across 1 country: United States