In-hospital Cardiopulmonary Resuscitation With Balloon Occlusion of the Descending Aorta

NCT07434726 | Recruiting DMC FDA Device

• 1 other identifier: CPReboa
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test if a sustained Return of Spontaneous Circulation (ROSC) in patients with cardiac arrest is more frequent when patients receive advanced cardiac life support (ACLS) alone or when they receive ACLS plus a balloon occlusion of the thoracic aorta.

Conditions

Cardiac Arrest

Keywords

Cardiac Arrest; resuscitative endovascular occlusion of the aorta REBOA; cardio pulmonary resuscitation CPR; advanced cardiac life support ACLS

Outcome Measures

Primary Outcomes (1)

• Sustained ROSC

  Any return of spontaneous circulation lasting longer then 20 minutes

  Up to 1 hour after study inclusion

Secondary Outcomes (6)

• Survival to hospital discharge

  at hospital discharge, up to 90 days after study inclusion

• Survival to six month

  6 month after study inclusion

• neurologic outcome at the time of 30 days

  Day 30 after study inclusion

• neurologic outcome at the time of six month

  6 month after study inclusion

• ICU-free days before hospital discharge

  at hospital discharge, up to 90 days after study inclusion

Other Outcomes (4)

• non-invasive cerebral oxygenation during resuscitation

  Continuously assessed during ongoing resuscitation, up to 1 hour after study inclusion

• cause of death

  at six month

• Troponin T trajectory

  at inclusion, 30 minutes after inclusion and once up to day 3

Study Arms (2)

Advanced Cardiac Life Support (ACLS) alone

ACTIVE COMPARATOR

Advanced Cardiac Life Support (ACLS) as per the hospitals standard protocol, including advanced interventions such as extended cardio-pulmonary resuscitation (eCPR).

Other: Advanced Cardiac Life Support (ACLS)

Advanced Cardiac Life Support (ACLS) plus REBOA

EXPERIMENTAL

Advanced Cardiac Life Support (ACLS) as per the hospitals standard protocol, including advanced interventions such as eCPR plus resuscitative balloon occlusion of the descending thoracic aorta (REBOA).

Device: resuscitative endovascular occlusion of the aorta (REBOA); Other: Advanced Cardiac Life Support (ACLS)

Interventions

resuscitative endovascular occlusion of the aorta (REBOA) DEVICE

Insertion of a balloon catheter through the common femoral artery, retrograde advancement of the catheter into the descending thoracic aorta, ballon occlusion of the aorta

Advanced Cardiac Life Support (ACLS) plus REBOA

Advanced Cardiac Life Support (ACLS) OTHER

Advanced Cardiac Life Support (ACLS) as per American Heart Association (AHA) or European Resuscitation Council (ERC) standards

Advanced Cardiac Life Support (ACLS) alone; Advanced Cardiac Life Support (ACLS) plus REBOA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients suffering from in hospital cardiac arrest (IHCA), including patients with out of hospital cardiac arrest (OHCA) and return of spontaneous circulation (ROSC), transported to the emergency department, where they suffer a second arrest (IHCA)
• successful placement of a femoral artery introducer sheath
• any electrical cardiac activity seen in the initial rhythm analysis
• ongoing effort of resuscitation as determined by study-independent resuscitation lead

You may not qualify if:

• IHCA in the operating room, on intensive care unit or in the cardiac catheter laboratory
• hospital visitors suffering from cardiac arrest
• asystole seen in the initial rhythm analysis
• (presumed) age under 18 years
• known "do not resuscitate"-order
• known or obvious pregnancy
• traumatic cardiac arrest
• known aortic pathologies that render cannulation impossible
• known allergies to radiographic contrast agents

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital University Hospital Bern

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Interventions

Advanced Cardiac Life Support

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiopulmonary Resuscitation; Resuscitation; Emergency Treatment; Therapeutics; Life Support Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Wolf E Hautz, MD, MME

  Inselspital University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolf E Hautz, MD, MME

CONTACT

+41 31 632 57 01; wolf.hautz@insel.ch

Cornelia Lammbrigger, RN

CONTACT

+41 31 632 57 01; ukn.studynurse@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 27, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

CH (1)