Ventricular Tachycardia Clinical Trial
— UP-FRONTOfficial title:
Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)
Verified date | March 2023 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Single center randomized-controlled trial in out-of-hospital cardiac arrest (OHCA) patients. This study will investigate the feasibility and utility of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure using a REBOA catheter device in patients who have experienced an OHCA and have not regained return of spontaneous circulation (ROSC).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 31, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Apparent age between 18 - 70 years. 2. OHCA defined as receiving professional CPR or AED defibrillation 3. OHCA witnessed by bystanders or professional rescuers / UED personnel 4. VT/VF as the presenting rhythm for OHCA or clearly documented VT/VF during OHCA 5. Total time pulseless > 10 minutes Exclusion Criteria: 1. Obvious Pre-existing neurocognitive impairment precluding independent activities of daily living 2. Obvious or suspicion of anatomic abnormality preventing successful deployment of REBOA device (i.e. previous vascular surgery in access region, dialysis graft, etc.) 3. Clear non-cardiac etiology (traumatic, hanging, overdose, etc.) of cardiac arrest 4. Do-Not-Resuscitate order or comfort care measures in place prior to enrollment 5. Special populations (pregnant, prisoner, or cognitively impaired) 6. Total time pulseless greater than 20 minutes 7. Inability to determine when cardiac arrest occurred (or for OHCA arriving to UED via EMS, time of 911 call) and the time elapsed since |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to successful deployment of device | The device is successfully deployed when it raises the mean arterial pressure | Up to 10 minutes | |
Secondary | Return of spontaneous circulation (ROSC) | ROSC is when the heart begins beating on its own | Up to 60 minutes |
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