Long Term Follow-up of Cardiac Arrest Survivors Exposed to Ultra-rapid Cooling
Recruiting now
Conditions studied: Cardiac Arrest (CA), Resuscitated Sudden Cardiac Death, Post Cardiac Arrest Patient Who Was Treated by Hypothermia Protocol
In brief
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.
Key facts
- Study ID
- NCT07028372
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 12
- Starts
- 2025-06-11
- Expected to finish
- 2031-12-01
- Last updated by the study team
- 2026-03-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Follow-up refusal from patient of trusted person or the close relative or parent
- Having being included in the OverCool clinical investigation but not submitted to the Vent2Cool procedure
- Impossibility to reach the patient or the trusted person or the close relative or parent
Where it is running
- AP-HP Centre, Cochin Hospital, Medical Intensive Care Unit — Paris, France (enrolling)
- Angers University Hospital, Medical Intensive Care Unit, Vent'Lab — Angers, France
Full record on ClinicalTrials.gov
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