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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVTM system, therapeutic hypothermia | Induced therapeutic hypothermia post cardiac arrest |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZOLL Intravascular Temperature Management System (IVTM) | Device | Induced therapeutic hypothermia post cardiac arrest. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects in which IVTM can therapeutically cool patients as a measure of Performance | Day 1 |
| 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 |
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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
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Subjects that have experienced an out-of-hospital cardiac arrest.
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| Name | Affiliation | Role |
|---|---|---|
| Brian O'Neil, MD | Wayne State University, School of Medicine Specialist and Chief, Detroit Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital of Central Connecticut | New Britain | Connecticut | 06050 | United States | ||
| Wayne State University / Detriot Medical Center |
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| Detroit |
| Michigan |
| 48201 |
| United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Palmetto Health Clinical Trials Department | Columbia | South Carolina | 29203 | United States |
| Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| Chattanooga Center for Neurologic Research | Chattanooga | Tennessee | 37403 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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