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

NCT01847482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-06-27

No results posted yet for this study

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

DEVICE

ZOLL Intravascular Temperature Management System (IVTM)

Induced therapeutic hypothermia post cardiac arrest

Sponsors & Collaborators

  • Asahi Kasei Medical Co., Ltd.

    collaborator INDUSTRY

  • ZOLL Circulation, Inc., USA

    lead INDUSTRY

Principal Investigators

  • Yoichi Kato, PhD · Asahi Kasei Medical Co., Ltd.

  • Tsuyoshi Maekawa, MD, PhD · Yamaguchi Grand Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-06-30
Completion
2016-01-19

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01847482 on ClinicalTrials.gov