NEURESCUE aortic balloon catheter added to advanced cardiac life support
Official title: A Randomized Controlled Study of the NEURESCUE Device as an Adjunct to Advanced Cardiac Life Support
Run by neurescue · NCT06793033 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | neurescue Industry-sponsored |
| Locations | 2 sites (Berlin and 1 other locations) |
| Status | Recruiting |
| Started | July 7, 2025 |
| Main results expected | January 2027 |
| Study ends | March 2027 |
| Registry record updated | November 17, 2025 |
| Trial ID | NCT06793033 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.