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

This study has been completed.
Information provided by (Responsible Party):
ZOLL Circulation, Inc., USA Identifier:
First received: February 4, 2013
Last updated: July 27, 2015
Last verified: July 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 ]

Enrollment: 50
Study Start Date: July 2014
Study Completion Date: July 2015
Primary Completion Date: July 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
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Please refer to this study by its identifier: NCT01818388

United States, Connecticut
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Michigan
Wayne State University / Detriot Medical Center
Detroit, Michigan, United States, 48201
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029-6574
NewYork-Presbyterian/Columbia University Medical Center
New York, New York, United States, 10032
United States, South Carolina
Palmetto Health Clinical Trials Department
Columbia, South Carolina, United States, 29203
Greenville Hospital System
Greenville, South Carolina, United States, 29605
United States, Tennessee
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, United States, 37403
United States, Texas
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
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: July 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 November 27, 2015