NEURESCUE aortic balloon catheter added to advanced cardiac life support
A Randomized Controlled Study of the NEURESCUE Device as an Adjunct to Advanced Cardiac Life Support
NA · neurescue · NCT06793033
This trial will test whether adding the NEURESCUE aortic balloon catheter to standard advanced cardiac life support helps adults (18–80) with witnessed cardiac arrest and non-shockable rhythms achieve return of spontaneous circulation and better outcomes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | neurescue (industry) |
| Locations | 2 sites (Berlin and 1 other locations) |
| Trial ID | NCT06793033 on ClinicalTrials.gov |
What this trial studies
Adults with witnessed cardiac arrest who receive CPR quickly and meet inclusion criteria will be randomized to receive either standard advanced cardiac life support (ACLS) alone or ACLS plus aortic balloon occlusion (ABO) using the NEURESCUE device. The catheter is inserted via the femoral artery and a soft balloon is temporarily inflated in the descending aorta to redirect blood toward the heart and brain, with inflation controlled by the NEURESCUE Assistant. Cardiac rhythm and return of spontaneous circulation (ROSC) will be closely monitored during treatment and subjects will have follow-up visits including a 90-day assessment. The study compares clinical safety and performance between the two approaches to see if ABO provides additional benefit when used with ACLS.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–80 with a witnessed cardiac arrest, CPR started within 7 minutes, CPR duration under 40 minutes at enrollment, and a non-shockable initial rhythm.
Not a fit: Patients with traumatic cardiac arrest, known pregnancy, terminal illness, existing do-not-attempt-CPR orders, opposition to participation, or those with shockable rhythms are not eligible and are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding NEURESCUE ABO could increase rates of ROSC and improve short-term survival and neurologic outcomes after cardiac arrest.
How similar studies have performed: Small observational studies and animal data have suggested that aortic occlusion can boost cerebral and coronary perfusion during arrest, but randomized controlled evidence is limited and the NEURESCUE intelligent balloon system is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Berlin and 1 other locations
- Charité - Universitätsklinikum Berlin — Berlin, Germany (RECRUITING)
- University Hospital Heidelberg — Heidelberg, Germany (RECRUITING)
Study contacts
- Study coordinator: Michael Preusch, M.D.
- Email: Michael.Preusch@med.uni-heidelberg.de
- Phone: +49 151 40044669
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Arrest, Cardiopulmonary Arrest