Cardiac Arrest Clinical Trials

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Long Term Follow-up of Cardiac Arrest Survivors Exposed to Ultra-rapid Cooling, a Prospective Non-interventional Cohort

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

Less than 10% of patients eliciting out-of-hospital cardiac arrest (OHCA) survive, although 30% can be resuscitated by Emergency services before admission in Intensive Care Units (ICU). The majority succumb to Post-Cardiac Arrest Syndrome (PCAS). PCAS is associated with high mortality (60-70%) and morbidity. One proposed method of preventing the neurological and cardiac consequences of PCAS is to lower the body temperature to 33°C as quickly as possible. This approach is known as therapeutic hypothermia or Targeted Temperature Management (TTM). The Vent2Cool system, developed by Orixha, is a novel approach that enables the rapid induction of therapeutic hypothermia by using hypothermic Total Liquid Ventilation (TLV) to reach a protective temperature of 33°C within minutes. The OverCool feasibility study, which started in April 2025, is designed to validate the clinical performance and safety of an ultra-rapid cooling approach combining ultra-rapid hypothermia induction using the Vent2Cool system, and maintenance and rewarming using the ArcticSun system. The AfterCool study aims to evaluate long-term outcomes during a five-year follow-up of cardiac arrest survivors who were treated with ultrarapid cooling in the OverCool study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age of 18 years and over

• Cardiac arrest patient included in and alive at the end of the OverCool clinical investigation (28 days after the cardiac arrest)

• Non-opposition from the patient or the trusted person or the close relative or parent obtained within 3 months after the end of the OverCool study

Locations
Other Locations
France
Angers University Hospital, Medical Intensive Care Unit, Vent'Lab
NOT_YET_RECRUITING
Angers
AP-HP Centre, Cochin Hospital, Medical Intensive Care Unit
RECRUITING
Paris
Contact Information
Primary
Alain CARIOU, MD PhD
alain.cariou@aphp.fr
+33 1 58 41 25 01
Time Frame
Start Date: 2025-06-11
Estimated Completion Date: 2031-12
Participants
Target number of participants: 12
Treatments
Resuscitated OverCool clinical investigation participants alive at 28 days after cardiac arrest
Patients who were resuscitated after cardiac arrest, treated with ultrarapid cooling as part of the OverCool clinical investigation and survived until the end of the investigation (28 days after cardiac arrest and subsequent Vent2Cool treatment).
Sponsors
Collaborators: ORIXHA
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov