Cardiac Arrest (CA), Cardiopulmonary Arrest
Conditions
Brief summary
The NEURESCUE device is the first intelligent balloon catheter for aortic balloon occlusion (ABO), an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment. The catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the descending to redirect blood flow towards the upper body. The purpose of this study is to compare the clinical safety and performance of Advanced Cardiovascular Life Support (ACLS) versus ACLS in combination with Aortic Balloon Occlusion (ABO) using the NEURESCUE device in subjects with cardiac arrest.
Detailed description
Subjects will be randomized into two arms: ACLS treatment or ACLS + ABO treatment. Those in the ACLS treatment arm will receive standard of care treatment for cardiac arrest, while those in Arm 2 will receive ACLS in combination with ABO. The NEURESCUE device is an aortic balloon catheter designed to temporarily occlude the aorta. During the treatment, the NEURESCUE Catheter will be placed in the descending aorta and be connected to the NEURESCUE Assistant. The NEURESCUE Assistant facilitates pressure-regulated inflation and deflation of the balloon. Throughout the treatment, cardiac rhythm and return of spontaneous circulation (ROSC) will be monitored. The subject will be monitored for a total of 4 visits, where a 90-days follow-up will account for the last visit.
Interventions
PROCEDUREAdvanced Cardiac Life Support (ACLS)
Standard of care Advanced Cardiac Life Support (ACLS) consists of cardiopulmonary resuscitation (CPR), airway management, ventilation and defibrillation.
DEVICEAortic balloon occlusion (ABO)
Aortic balloon occlusion (ABO) is a technique that diverts blood flow towards the coronary and cerebral circulation. ABO is investigated as an adjunct to the treatment of cardiac arrest. In this study ABO is performed using the NEURESCUE Catheter, which is inserted through an introducer in the femoral artery, and thereby inserted into the aorta during uninterrupted Advanced Cardiac Life Support (ACLS). The balloon is then temporarily inflated as an adjunct to the treatment of cardiac arrest.
Sponsors
neurescue
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 and ≤80 years * Witnessed arrest * CPR initiated within 7 min of arrest * CPR time less than 40 min at enrollment * Non-shockable rhythm
Exclusion criteria
* Traumatic cardiac arrest * Known pregnancy * Known terminal disease * Known do-not-attempt-CPR order * Known opposition to study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resuscitation | Measured from 10 minutes after randomization to 70 minutes after randomization | Subject achieving shockable rhythm or ROSC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedures | Measured from 10 minutes after randomization to 90 days post cardiac arrest | Need for any invasive procedures, e.g. surgery, extracorporeal membrane oxygenation (ECMO) or percutaneous coronary intervention (PCI) |
| (S)A(D)E | Measured from randomization to 90 days post cardiac arrest | All Anticipated (S)AEs/(S)ADEs and Unanticipated (S)AEs/(S)ADEs |
| Epinephrine | Measured from 10 minutes after randomization to 70 minutes after randomization | Dosage of epinephrine administered during resuscitation |
| EQ-5D | Measured 90 days post cardiac arrest | EQ-5D is a standardized measure of quality of life |
| Survival | Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest | Survival at discharge or 7 day post cardiac arrest (whichever comes first), and survival at 90 days post cardiac arrest |
| CPC score | Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest | Cerebral Performance Category (CPC) is a five-point scale used to categorize the neurological outcome after cardiac arrest |
Countries
Germany
Contacts
Primary ContactMichael Preusch, M.D.
Outcome results
None listed