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

OR:

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.