Clinical trial Recruiting at 1 site Observational Ages 18 and up

Long-term follow-up of cardiac arrest survivors treated with ultra-rapid cooling

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

Run by Assistance Publique - Hôpitaux de Paris · NCT07028372 · Data updated 2026-11-12

This follow-up will see if people who survived cardiac arrest after ultra-rapid cooling with Vent2Cool have better long-term function and quality of life.

More Cardiac Arrest (CA) trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment12 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations2 sites (Angers and 1 other locations)
StatusRecruiting
StartedJune 11, 2025
Main results expectedDecember 2031
Study endsDecember 2031
Registry record updatedMarch 24, 2026
Trial IDNCT07028372 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) who were included in the OverCool investigation, received the Vent2Cool procedure, and were alive 28 days after cardiac arrest with no opposition to follow-up.

Probably not a fit

Patients who were included but did not receive the Vent2Cool procedure, those who refuse follow-up, or those who cannot be reached are not eligible and will not benefit from this follow-up.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational long-term follow-up of adults who were enrolled in the OverCool investigation and received ultra-rapid cooling with the Vent2Cool system, with inclusion limited to those alive 28 days after cardiac arrest. Data collection includes patient-reported outcomes and functional measures such as the SF-36, modified Rankin Score, ADL questionnaire, NYHA class, and SGRQ, obtained with non-opposition/consent within three months after the parent study. The study is conducted at participating French centers (Angers University Hospital and AP-HP Cochin Hospital) and documents morbidity, mortality, and quality-of-life trajectories after post-cardiac arrest syndrome. The aim is to characterize long-term safety, functional recovery, and respiratory and cardiac status following ultra-rapid hypothermia induction by total liquid ventilation.

Why it matters

Potential benefit: If successful, this follow-up could show that ultra-rapid cooling reduces long-term neurological and cardiac complications and improves survivors' quality of life.

How similar studies have gone: External targeted temperature management trials have shown mixed results, while animal studies and limited human data suggest earlier cooling is beneficial; hypothermic total liquid ventilation (Vent2Cool) is a novel approach with limited clinical experience to date.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

  • AP-HP Centre, Cochin Hospital, Medical Intensive Care Unit
    Paris, France
    Recruiting
  • Angers University Hospital, Medical Intensive Care Unit, Vent'Lab
    Angers, France
    Not yet recruiting

Study contacts

  • Principal investigator: Alain CARIOU, MD PhD — AP-HP, Cochin Hospital, Intensive Care and Resuscitation Department
  • Study coordinator: Alain CARIOU, MD PhD
  • Email: alain.cariou@aphp.fr
  • Phone: +33 1 58 41 25 01

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.