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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
Standard of care Advanced Cardiac Life Support (ACLS) consists of cardiopulmonary resuscitation (CPR), airway management, ventilation and defibrillation.
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.
Charité - Universitätsklinikum Berlin
Berlin, Germany
RECRUITINGUniversity Hospital Heidelberg
Heidelberg, Germany
RECRUITINGResuscitation
Subject achieving shockable rhythm or ROSC
Time frame: Measured from 10 minutes after randomization to 70 minutes after randomization
Epinephrine
Dosage of epinephrine administered during resuscitation
Time frame: Measured from 10 minutes after randomization to 70 minutes after randomization
Procedures
Need for any invasive procedures, e.g. surgery, extracorporeal membrane oxygenation (ECMO) or percutaneous coronary intervention (PCI)
Time frame: Measured from 10 minutes after randomization to 90 days post cardiac arrest
(S)A(D)E
All Anticipated (S)AEs/(S)ADEs and Unanticipated (S)AEs/(S)ADEs
Time frame: Measured from randomization to 90 days post cardiac arrest
CPC score
Cerebral Performance Category (CPC) is a five-point scale used to categorize the neurological outcome after cardiac arrest
Time frame: Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest
EQ-5D
EQ-5D is a standardized measure of quality of life
Time frame: Measured 90 days post cardiac arrest
Survival
Survival at discharge or 7 day post cardiac arrest (whichever comes first), and survival at 90 days post cardiac arrest
Time frame: Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest
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