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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by ZOLL Circulation, Inc., USA
Information provided by (Responsible Party):
ZOLL Circulation, Inc., USA Identifier:
First received: February 4, 2013
Last updated: February 27, 2015
Last verified: February 2015

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.

Condition Intervention
Out of Hospital Cardiac Arrest
Device: ZOLL Intravascular Temperature Management System (IVTM)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicenter, Prospective, Single Arm Observational Trial to Assess Intravascular Temperature Management (IVTM) in the Treatment of Cardiac Arrest

Resource links provided by NLM:

Further study details as provided by ZOLL Circulation, Inc., USA:

Primary Outcome Measures:
  • Proportion of subjects in which IVTM can therapeutically cool patients as a measure of Performance [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ability to Enroll Subjects, Proportion of those Enrolled that Complete the Study Protocol and Time to complete Enrollment of 50 Subjects Defined as Retention [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
  • Incident Adverse Events Defined as Safety [ Time Frame: Up to 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: July 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IVTM system, therapeutic hypothermia
Induced therapeutic hypothermia post cardiac arrest
Device: ZOLL Intravascular Temperature Management System (IVTM)
Induced therapeutic hypothermia post cardiac arrest.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects that have experienced an out-of-hospital cardiac arrest.


Inclusion criteria:

  1. Signed informed consent
  2. 18 years of age or older
  3. Out-of-hospital witnessed cardiac arrest with any rhythm [Ventricular Fibrillation/Tachycardia (VF/VT), Pulseless Electrical Activity (PEA), or Asystole (AS)] during EMS phase of treatment


    Out-of-hospital unwitnessed cardiac arrest with VF upon EMS arrival

  4. Lack of meaningful response to verbal commands upon arrival to hospital after suffering non-traumatic cardiac arrest in an out-of-hospital setting
  5. Return of spontaneous circulation (ROSC) within 30 minutes of EMS arrival
  6. Able to maintain a SBP > 90mmHg for 30 minutes post ROSC without the use of pressors OR with stable dose of pressors (if escalation of pressors is required, patient is not eligible)
  7. Undergoing Therapeutic Hypothermia using ZOLL's IVTM System within twelve hours of ROSC BUT should have been initiated as soon as possible

Exclusion Criteria

  1. Traumatic cardiac arrest [due to blunt trauma, penetrating injury (e.g., stabbing, gunshot, etc.), burns, exsanguinations, strangulation, smoke inhalation, electrocution, hanging, drowning, etc.]
  2. Toxicological etiology (e.g., inhalation of toxic substances, drugs, etc.)
  3. Known or suspected pregnancy
  4. Do Not Attempt to Resuscitate (DNAR) order in force
  5. Ward of the state or prisoner
  6. Anatomy, previous surgery or disease state contraindicating femoral venous access
  7. Received neuromuscular blocking agents or central nervous system sedatives whose effects have not worn off prior to assessing level of consciousness following ROSC
  8. Hypothermia initiated at a transferring facility prior to arrival at the enrolling hospital (excludes pre-hospital IV fluids or cold packs for cooling by EMS)
  9. Current Inferior Vena Cava (IVC) filter
  10. Known history of acute neurological illness or severe functional disabilities prior to arrest (e.g., seizures, traumatic brain injury, increased intracranial pressures, intracerebral hemorrhage, etc.)
  11. Known heparin allergy
  12. Known allergy to any adjunctive pharmacologic agent required for induction or maintenance of therapeutic hypothermia
  13. Known history of bleeding or blood disorders such as coagulopathy, cryoglobulinemia, sickle cell or thrombocytopenia with a platelet count below 40,000.
  14. Known hypersensitivity to hypothermia including a history of Raynaud's disease
  15. Evidence of intracranial bleed
  16. Terminal illness or life expectancy of less than 3 months prior to arrest
  17. Currently enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this trial's endpoints Note: For the purpose of this protocol, subjects involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01818388

Contact: Renee Kochevar, PhD, ALM 408-419-2904

United States, Connecticut
The Hospital of Central Connecticut Recruiting
New Britain, Connecticut, United States, 06050
Contact: Justin Lundbye, M.D.    860-224-5731   
Contact: Deborah Katten    860-545-1537    dkatten@harthosp.rg   
Principal Investigator: Justin Lundbye, M.D., M.D.         
United States, Michigan
Wayne State University / Detriot Medical Center Recruiting
Detroit, Michigan, United States, 48201
Contact: Gregory Norris    313-745-1540   
Contact: Robert Kas-Shamoun, RN    313-745-4414   
Principal Investigator: Gregory Norris         
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Kelly Sawyer, M.D.    248-898-0189   
Contact: Ryan Paternoster    248-898-6005   
Principal Investigator: Kelly Sawyer, M.D.         
United States, Minnesota
Minneapolis Heart Institute Foundation Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Mike Mooney, M.D.    603-650-7047   
Contact: Dave Hildebrandt    612-863-4085   
Principal Investigator: Mike Mooney, M.D.         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Not yet recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Alan Kono, M.D    603-650-2929   
Contact: Norman Paradis, M.D    603-650-7047   
Principal Investigator: Alan Kono, M.D         
United States, New York
Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029-6574
Contact: Stephan Mayer, MD, FCCM   
Contact: Christine Crabtree    212.241.2397   
Principal Investigator: Stephan ayer, MD, FCCM         
NewYork-Presbyterian/Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact: Jan Claassen, MD,PhD    212-305-7236   
Contact: Cristina Falo    212.305.6071   
Principal Investigator: Jan Claassen, MD,PhD         
United States, South Carolina
Palmetto Health Clinical Trials Department Recruiting
Columbia, South Carolina, United States, 29203
Contact: J. Kyle Hewett, M.D.    803-434-3800   
Contact: Heather Homolek    803-434-6365   
Principal Investigator: J. Kyle Hewett, M.D.         
Greenville Hospital System Not yet recruiting
Greenville, South Carolina, United States, 29605
Contact: Jesse Jorgensen, M.D.    864-455-6900   
Contact: Maureen Coyne    864-455-7727   
Principal Investigator: Jesse Jorgensen, M.D.         
United States, Tennessee
Chattanooga Center for Neurologic Research Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Katrina Barton    423-648-0304   
Principal Investigator: Thomas Devlin, MD, PhD         
United States, Texas
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Pratik Doshi, M.D.    713-500-7585   
Contact: Misha N Granado, MPH,MS    713-500-5446   
Principal Investigator: Pratik Doshi, M.D.         
Sub-Investigator: Kunal Sharma         
Sponsors and Collaborators
ZOLL Circulation, Inc., USA
Principal Investigator: Brian O'Neil, MD Wayne State University, School of Medicine Specialist and Chief, Detroit Medical Center
  More Information

No publications provided

Responsible Party: ZOLL Circulation, Inc., USA Identifier: NCT01818388     History of Changes
Other Study ID Numbers: EDC-1978
Study First Received: February 4, 2013
Last Updated: February 27, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Cardiovascular Diseases
Heart Diseases processed this record on July 26, 2015