Resuscitative EndoVascular Aortic Occlusion for Maximal Perfusion
Completed · Early Phase 1
Conditions studied: Cardiac Arrest
In brief
REBOA is an endovascular technique that is becoming more widely used in the setting of severe trauma. It is a procedure where one uses the seldigner technique to advance a balloon tipped catheter into the femoral artery and then into the aorta. The balloon is then inflated to fully occlude blood flow to the distal aorta. Study investigators hypothesize that this technique may be of use in the setting of medical cardiac arrest. By occluding the aorta and preventing distal blood flow during CPR, physicians might maximize perfusion to the heart and the brain, and promote return of spontaneous circulation and neurologic recovery. Investigators plan to conduct an IDE approved early feasibility study using the ER-REBOA catheter in five patients who are in cardiac arrest of medical (i.e. non-traumatic) etiology. The primary outcomes will be feasibility and safety. Secondary outcomes will focus on procedural performance, hemodynamic response to aortic occlusion, and patient-centered outcome variables. Investigators plan to expand the study to an additional 15 patients if, after the initial five patients, the risk-benefit profile remains favorable.
Key facts
- Study ID
- NCT03703453
- Run by
- Yale University
- People needed
- 5
- Starts
- 2020-01-28
- Expected to finish
- 2021-04-29
- Last updated by the study team
- 2021-08-24
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The patient must have had a witnessed cardiac arrest2 of suspected medical etiology
- CPR initiation within approximately 6 minutes of collapse (as estimated based on history provided by EMS), either by EMS, hospital personnel, or a bystander
You may not qualify if…
- Known active terminal illness or severe dementia
- Known aortic disease
- Age 80 or older
- Total resuscitation time greater than approximately 45 minutes (from start of CPR)
- Age less than 18
- Wards of the state
- Known or suspected (by physical exam or history) pregnancy
- Suspected traumatic cause of cardiac arrest
- Known Do Not Resuscitate (DNR) orders
- Anticipated difficult procedure (e.g. signs of peripheral vascular disease, severe obesity, or otherwise deemed likely to be difficult by enrollment staff)
Where it is running
- Yale New Haven Hospital — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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