Resuscitative EndoVascular Aortic Occlusion for Maximal Perfusion
Condition: Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Interventional
Phase: Early Phase 1

Summary: 
      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.
    

Detailed description: 
      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 two phases, with a different primary outcome in each
      phase. Phase 1 of the study is expected to occur over a period of 1 year. Phase 2 expected
      duration is 1.5 years. Each phase of the study will require separate FDA/IRB approval.
      Enrollment will take place at Yale-New Haven Hospital in New Haven, CT, the primary site for
      Phase 1 and Phase 2 of the study. A potential secondary site, the University of California,
      Davis, has been approved for trial participation but will not contribute to enrollment during
      Phase 1.

      Phase 1 will primarily examine the feasibility and safety 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 procedural performance, hemodynamic response to aortic occlusion, and
      patient-centered outcome variables. 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.
    

Intervention name(s): ER-REBOA catheter
Intervention type(s): Device
Intervention description(s): 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).
Intervention model: Single Group Assignment
Intervention model description: REBOA in medical cardiac arrest patients
Masking: None (Open Label)
Primary purpose: Treatment