Cardiac Rhythm DisorderCAVA-ECMONCT05788120
Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by ECMO-VA for Refractory Cardiogenic Shock
An observational study of Cardiac Rhythm Disorder, run by Assistance Publique - Hôpitaux de Paris at 20 sites in France.
Trial summary
Brief Summary : Rhythm disorders are a frequent and potentially serious complication of critical patients in the ICU and postoperative cardiac surgery. In particular, atrial fibrillation (AF) is the most common rhythm disorder in patients admitted to the ICU and is associated with excess mortality during acute… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rhythm Disorder
- What is being tested?
- Follow up by phone call
- How many people
- 600 participants
- Where
- 20 sitesFrance
- Study dates
- 28 Apr 2023to 28 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major Patients Assisted by VA ECMO in Intensive care
Who may be able to join
- Patient 18 years of age or older
- Assistance with VA ECMO
Who cannot join
- Opposition to the use of data.
- Persons under legal protection (curators, guardianship), judicially safeguarded.
- VA ECMO for refractory cardiac arrest.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
France20 sites, 19 recruiting
- Recruiting
CHU Angers
Angers, 49100
Emmanuel Pr RINEAU, +33 2 41 35 39 51, Emmanuel.Rineau@chu-angers.fr
- Recruiting
Hospices Civils de Lyon - Hôpital Louis Pradel
Bron, 69500
FELLAHI Pr Jean-Luc, +33 4 72 11 89 33, jean-luc.fellahi@chu-lyon.fr
- Recruiting
CHU Caen Normandie - Hôpital Côte de Nacre
Caen, 14000
Alina Dr DENISENKO, denisenko-a@chu-caen.fr
- Not yet recruiting
CHRU Tours - Hôpital Trousseau
Chambray-lès-Tours, 37170
Sabrina Dr CHETOUNE, +33 2 47 47 47 47, S.CHETOUANE@chu-tours.fr
- Recruiting
CHU Dijon Bourgogne - Hôpital François Mitterrand
Dijon, 21000
Pierre-Grégoire Pr GUINOT, guinotpierregregoire@gmail.com
- Recruiting
CHU Grenoble Alpes - Site Nord
Grenoble, 38700
Alexandre Dr BEHOUCHE, ABehouche@chu-grenoble.fr
- Not yet recruiting
CHU Lille - Institut Cœur Poumon
Lille, 59000
Benoit BRASSART, +33 3 20 44 59 62, Benoit.BRASSART@chu-lille.fr
- Recruiting
CHU Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, 34295
Phillipe Dr GAUDARD, p-gaudard@chu-montpellier.fr
- Recruiting
CHU Nantes - Hôpital Nord Laennec
Nantes, 44000
Bertrand Pr Rozec, +33 2 40 16 53 04, bertrand.rozec@chu-nantes.fr
- Recruiting
Pitié Salpêtrière Hospital, Intensive Care Unit - Resuscitation
Paris, 75013
Alain Pr COMBES, +33 1 42 16 38 18, alain.combes@aphp.fr
- Recruiting
Pitié-Salpêtrière Hospital, Cardiovascular Surgery Intensive Care Unit
Paris, 75013
Adrien Pr Bouglé, +33 1 42 16 29 91, adrien.bougle@aphp.fr
- Recruiting
Hôpital Européen Georges Pompidou
Paris, 75015
Hélène Dr NOUGUE, +33 1 56 09 25 94, helene.nougue@aphp.fr
- Recruiting
Hôpital Bichat
Paris, 75018
Sophie Dr PROVENCHERE, +33 1 40 25 83 55, sophie.provenchere@aphp.fr
- Recruiting
Hôpital Bichat
Paris, 75018
Romain Pr SONNEVILLE, +33 1 40 25 61 39, romain.sonneville@aphp.fr
- Not yet recruiting
CHU Bordeaux - Hôpital cardiologique, GH Sud Pessac
Pessac, 33600
Antoine Dr BEURTON, +33 5 56 79 56 79, antoine.beurton@chu-bordeaux.fr
- Recruiting
CHU Rennes, Hôpital Pontchaillou
Rennes, 35000
Nicolas Dr NESSELER, nicolas.nesseler@chu-rennes.fr
- Completed
Hôpitaux universitaires de Strasbourg - Hôpital Civil
Strasbourg, 67000
- Recruiting
CHU Toulouse - Hôpital de Rangueil
Toulouse, 31300
Fanny Dr BOUNES-VARDON, +33 5 61 32 27 99, bounes.f@chu-toulouse.fr ; vardon.f@chu-toulouse.fr
- Recruiting
CHU Toulouse - Hôpital de Rangueil
Toulouse, 31300
François Dr LABASTE, +33 5 61 32 28 22, labaste.f@chu-toulouse.fr
- Recruiting
CHRU Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54500
Phillipe Pr GUERCI, +33 3 83 15 79 95, p.guerci@chru-nancy.fr
About this study
Official title: Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by Extra Corporeal Membrane Oxygenation Veno-arterial (ECMO VA) for Refractory Cardiogenic Shock
Brief Summary : Rhythm disorders are a frequent and potentially serious complication of critical patients in the ICU and postoperative cardiac surgery. In particular, atrial fibrillation (AF) is the most common rhythm disorder in patients admitted to the ICU and is associated with excess mortality during acute circulatory failure. In postoperative cardiac surgery, AF affects 15 to 45% of patients. In addition to hemodynamic effects, AF increases the risk of stroke, bleeding, respiratory or renal failure, and doubles mortality at 30 days and 6 months. In the longer term, the recurrence rate of AF within 1 year after hospital discharge is about 50%. Similarly, other rhythm disorders, supraventricular or ventricular, can be life-threatening in ICU patients.
While the incidence and complications of rhythm disorders are well documented during sepsis, cardiogenic shock or after cardiac surgery, there are to our knowledge no data on the frequency and complications of rhythm disorders in patients assisted by VA ECMO.
The primary objective is to describe the incidence of supraventricular rhythm disorders in patients assisted by VA ECMO.
Read the detailed description
This study is an observational study to describe the conditions of occurrence of arrhythmias, particularly atrial fibrillation, in patients supported by VA ECMO, as well as their short-term and long-term prognosis. Patients will be recruited from the intensive care units and CRFs will be completed by the investigators at each of the participating centers. Data will be collected directly from the medical records, except for vital status at 1 year, which may be collected by telephone from the patient by the investigator at the center in the absence of data in the medical record.
Atrial fibrillation episodes will be recorded on a 12-lead electrocardiogram and securely transmitted to the coordinating center. In addition, investigators will send weekly data to the principal investigator for incidence calculation. Patients or their relatives will be informed about the study by an information sheet presented and explained by the investigator or another person authorized to conduct the research. The investigator will record the patient's consent in the patient's medical record.
- Conditions
- Cardiac Rhythm Disorder
- Being tested
- Follow up by phone call
- Keywords
- Arrhythmia, Veno-arterial Extra Corporeal Membrane, Oxygenation (VA ECMO), Cardiogenic shock.
- Medical subject headings
- Arrhythmias, Cardiac, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up by phone callOther
Centralized review of ECGs by the Pitié-Salpêtrière rhythmology department and collection of vital status at 12 months (if information not available, telephone call to the patient)
| Study group | Role | What they receive |
|---|---|---|
| Patients with refractory cardiogenic shock assisted with ECMO VA | Not described Receives: Other: Follow up by phone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of atrial fibrillation in patients assisted by veno-arterial ECMO.
Atrial fibrillation will be defined as an episode of AF ≥ 30 minutes or requiring pharmacological or electrical cardioversion.
Measured: day 30
Secondary outcomes (8)
Number of ventricular rhythm disorders
ventricular tachycardia, ventricular fibrillation
Measured: day 30
duration of VA ECMO support
duration of VA ECMO support
Measured: day 30
duration of ICU stay
duration of ICU stay
Measured: day 30
duration of mechanical ventilation
duration of mechanical ventilation
Measured: day 30
Number of living patient
Number of living patient
Measured: day 28, day 360
Number of thrombo-embolic complications
acute limb ischemia, circuit thrombosis, membrane thrombosis
Measured: day 30
Number of neurological complications
ischemic and hemorrhagic stroke
Measured: day 30
Number of bleeding complications
bleeding requiring transfusion of packed red blood cells (> 3 units / 24h) or requiring surgical intervention or interventional procedure (digestive or implantation site bleeding, need for revision surgery
Measured: day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start28 Apr 2023
- Primary completion28 Apr 2028 (estimated)
- Study completion28 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Rhythm DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788120
- Sponsor's protocol ID
- APHP221056
- Acronym
- CAVA-ECMO
- Status last verified
- Apr 2026
- First submitted
- 6 Mar 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by Extra Corporeal Membrane Oxygenation Veno-arterial (ECMO VA) for Refractory Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT05788120
- Acronym / sponsor ID
- CAVA-ECMO / APHP221056
- Conditions
- Cardiac Rhythm Disorder
- Keywords
- Arrhythmia, Veno-arterial Extra Corporeal Membrane, Oxygenation (VA ECMO), Cardiogenic shock.
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 28 Apr 2028 (estimated)
- Study completion
- 28 Apr 2028 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brief Summary : Rhythm disorders are a frequent and potentially serious complication of critical patients in the ICU and postoperative cardiac surgery. In particular, atrial fibrillation (AF) is the most common rhythm disorder in patients admitted to the ICU and is associated with excess mortality during acute circulatory failure. In postoperative cardiac surgery, AF affects 15 to 45% of patients. In addition to hemodynamic effects, AF increases the risk of stroke, bleeding, respiratory or renal failure, and doubles mortality at 30 days and 6 months. In the longer term, the recurrence rate of AF within 1 year after hospital discharge is about 50%. Similarly, other rhythm disorders, supraventricular or ventricular, can be life-threatening in ICU patients.
While the incidence and complications of rhythm disorders are well documented during sepsis, cardiogenic shock or after cardiac surgery, there are to our knowledge no data on the frequency and complications of rhythm disorders in patients assisted by VA ECMO.
The primary objective is to describe the incidence of supraventricular rhythm disorders in patients assisted by VA ECMO.
Detailed description
This study is an observational study to describe the conditions of occurrence of arrhythmias, particularly atrial fibrillation, in patients supported by VA ECMO, as well as their short-term and long-term prognosis. Patients will be recruited from the intensive care units and CRFs will be completed by the investigators at each of the participating centers. Data will be collected directly from the medical records, except for vital status at 1 year, which may be collected by telephone from the patient by the investigator at the center in the absence of data in the medical record.
Atrial fibrillation episodes will be recorded on a 12-lead electrocardiogram and securely transmitted to the coordinating center. In addition, investigators will send weekly data to the principal investigator for incidence calculation. Patients or their relatives will be informed about the study by an information sheet presented and explained by the investigator or another person authorized to conduct the research. The investigator will record the patient's consent in the patient's medical record.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with refractory cardiogenic shock assisted with ECMO VA | – | Other: Follow up by phone call |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major Patients Assisted by VA ECMO in Intensive care
Key inclusion criteria (2 listed)
- Patient 18 years of age or older
- Assistance with VA ECMO
Key exclusion criteria (3 listed)
- Opposition to the use of data.
- Persons under legal protection (curators, guardianship), judicially safeguarded.
- VA ECMO for refractory cardiac arrest.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow up by phone callCentralized review of ECGs by the Pitié-Salpêtrière rhythmology department and collection of vital status at 12 months (if information not available, telephone call to the patient) | Other | Patients with refractory cardiogenic shock assisted with ECMO VA |
Primary outcome
Number of atrial fibrillation in patients assisted by veno-arterial ECMO.
Time frame: day 30
Atrial fibrillation will be defined as an episode of AF ≥ 30 minutes or requiring pharmacological or electrical cardioversion.
8 secondary outcomes
Number of ventricular rhythm disorders
Time frame: day 30
duration of VA ECMO support
Time frame: day 30
duration of ICU stay
Time frame: day 30
duration of mechanical ventilation
Time frame: day 30
Number of living patient
Time frame: day 28, day 360
Number of thrombo-embolic complications
Time frame: day 30
Number of neurological complications
Time frame: day 30
Number of bleeding complications
Time frame: day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Rhythm Disorder, run by Assistance Publique - Hôpitaux de Paris at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrien Bougle, PhD (+33 1 42 16 29 91, Adrien.bougle@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of atrial fibrillation in patients assisted by veno-arterial ECMO. (time frame: day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.