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

Inclusion criteria

• Signed informed consent
• 18 years of age or older
• 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

• Lack of meaningful response to verbal commands upon arrival to hospital after suffering non-traumatic cardiac arrest in an out-of-hospital setting
• Return of spontaneous circulation (ROSC) within 30 minutes of EMS arrival
• 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)
• Undergoing Therapeutic Hypothermia using ZOLL's IVTM System within twelve hours of ROSC BUT should have been initiated as soon as possible

Exclusion criteria

• Traumatic cardiac arrest [due to blunt trauma, penetrating injury (e.g., stabbing, gunshot, etc.), burns, exsanguinations, strangulation, smoke inhalation, electrocution, hanging, drowning, etc.]
• Toxicological etiology (e.g., inhalation of toxic substances, drugs, etc.)
• Known or suspected pregnancy
• Do Not Attempt to Resuscitate (DNAR) order in force
• Ward of the state or prisoner
• Anatomy, previous surgery or disease state contraindicating femoral venous access
• Received neuromuscular blocking agents or central nervous system sedatives whose effects have not worn off prior to assessing level of consciousness following ROSC
• 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)
• Current Inferior Vena Cava (IVC) filter
• 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.)
• Known heparin allergy
• Known allergy to any adjunctive pharmacologic agent required for induction or maintenance of therapeutic hypothermia
• Known history of bleeding or blood disorders such as coagulopathy, cryoglobulinemia, sickle cell or thrombocytopenia with a platelet count below 40,000.
• Known hypersensitivity to hypothermia including a history of Raynaud's disease
• Evidence of intracranial bleed
• Terminal illness or life expectancy of less than 3 months prior to arrest
• 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.