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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Prospective, Single Arm Observational Trial to Assess Intravascular Temperature Management (IVTM) in the Treatment of Cardiac Arrest

Conditions
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Out of Hospital Cardiac Arrest

Intervention / Treatment
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* Device: ZOLL Intravascular Temperature Management System (IVTM)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IVTM system, therapeutic hypothermia<br>Induced therapeutic hypothermia post cardiac arrest | Device: ZOLL Intravascular Temperature Management System (IVTM)<br>* Induced therapeutic hypothermia post cardiac arrest.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects in which IVTM can therapeutically cool patients as a measure of Performance |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to Enroll Subjects, Proportion of those Enrolled that Complete the Study Protocol and Time to complete Enrollment of 50 Subjects Defined as Retention |  | Up to 90 days | 
| Incident Adverse Events Defined as Safety |  | Up to 90 days |