REBOA in Non-traumatic Cardiac Arrest

The proposed study will assess the safety, feasibility, and efficacy of the use of the
ER-REBOA™ catheter as a means of increasing cardio-cerebral perfusion in medical cardiac
arrest patients. The ER-REBOA™ catheter is a device that has been gaining increased use in
the setting of severe trauma for the purposes of stopping intra-abdominal hemorrhage. The
catheter is advanced through a femoral artery sheath into the aorta, where a balloon at its
tip is inflated, occluding all distal blood flow (and stopping any hemorrhage while the
patient can be prepared for definitive operative intervention).

Dr. Daley (along with previous investigators) has hypothesized that by using the device to
occlude distal blood flow during medical cardiac arrest, one might increase the perfusion to
the brain and heart, maximizing the patient's chance for cardiac and neurologic recovery.
Aortic occlusion for medical cardiac arrest is supported by robust pre-clinical literature,
but has not yet been studied in humans.

The proposed study is divided into three phases, with a different primary outcome in each
phase. Each phase of the study will require separate FDA/IRB approval. Enrollment will take
place at two sites, Yale (primary site) and the University of California, Davis (secondary
site).

Phase 1 will primarily examine the feasibility of the use of the ER-REBOA catheter in five
non-traumatic cardiac arrest patients. If deemed feasible and safe, the PI will request
permission from the FDA and the IRB to expand the study to Phase 2. Phase 2 will consist of
the enrollment of a subsequent 15 patients (20 in total for both phase 1 and 2) with a
primary focus on patient hemodynamics. Per our hypothesis, if the ER-REBOA catheter is
efficacious in medical cardiac arrest patients, an increase in systolic and diastolic blood
pressure should be evident after the inflation of the intra-aortic balloon. Phase 2 will
utilize the built in continuous arterial blood pressure monitoring capabilities of the device
to assess for a significant blood pressure increase after the deployment of the aortic
balloon.

If Phase 2 demonstrates improvements in hemodynamics when using the device and if the
risk-benefit profile of the device remains positive, investigators will request that the FDA
and IRB permit moving forward to phase 3. Phase 3 of the study will consist of a small (n=40)
randomized controlled trial with primary outcomes focusing on patient survival and the
neurologic status of survivors.

Inclusion Criteria:

- The patient must have had a witnessed cardiac arrest of suspected medical etiology and
CPR initiation within 6 minutes of collapse, either by EMS, hospital personnel, or a
bystander.

Exclusion Criteria:

- Known active terminal illness or severe dementia

- Known aortic disease

- Age 80 or older

- Total resuscitation time greater than 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