NCT01847482

Therapeutic Hypothermia With IntraVascular Temperature Management (IVTM) in Post-Cardiogenic Cardiac Arrest and Post-Return of Spontaneous Circulation Patients in Japan

COOL-ARREST JP: A Multicenter, Prospective, Single-arm Interventional Trial to Evaluate Therapeutic Hypothermia With IntraVascular Temperature Management (IVTM) in Post-Cardiogenic Cardiac Arrest and Post-Return of Spontaneous Circulation Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: ZOLL Circulation, Inc., USA · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, single-arm, prospective, interventional trial to evaluate therapeutic hypothermia with intravascular temperature management (IVTM) in post-cardiogenic cardiac arrest, post-return of spontaneous circulation (ROSC) patients in Japan. The objective of this study is to verify that therapeutic hypothermia performed by intravascular cooling using the investigational device (IVTM) can control body temperature appropriately in post-cardiogenic cardiac arrest, post-ROSC patients.

Conditions

• Cardiac Arrest

Interventions

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

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-06-01
• Completion: 2016-01-19
• First posted: 2013-05-06
• Last updated: 2018-06-27

Locations

10 sites across 1 country: Japan