Understanding heart rhythm disorders in patients on ECMO for severe heart failure
Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by Extra Corporeal Membrane Oxygenation Veno-arterial (ECMO VA) for Refractory Cardiogenic Shock
This study looks at how often heart rhythm problems, like atrial fibrillation, happen in patients on a special heart support machine for severe heart failure and what those problems mean for their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 20 sites (Angers and 19 other locations) |
| Trial ID | NCT05788120 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the occurrence and outcomes of cardiac rhythm disorders, particularly atrial fibrillation, in patients receiving veno-arterial extracorporeal membrane oxygenation (VA ECMO) for refractory cardiogenic shock. Data will be collected from intensive care units, focusing on both short-term and long-term prognosis of these arrhythmias. The study will utilize 12-lead electrocardiograms to document episodes of atrial fibrillation and will follow up with patients via phone calls to assess their vital status after one year. The findings will help clarify the incidence and complications associated with rhythm disorders in this critical patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18 years or older who are receiving VA ECMO for refractory cardiogenic shock.
Not a fit: Patients who are under legal protection or those receiving VA ECMO for refractory cardiac arrest may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for cardiac rhythm disorders in critically ill patients, potentially reducing mortality and morbidity.
How similar studies have performed: While the incidence of rhythm disorders in other critical conditions is documented, this specific focus on VA ECMO patients is novel and has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient 18 years of age or older * Assistance with VA ECMO Exclusion Criteria: * Opposition to the use of data. * Persons under legal protection (curators, guardianship), judicially safeguarded. * VA ECMO for refractory cardiac arrest.
Where this trial is running
Angers and 19 other locations
- CHU Angers — Angers, France (Recruiting)
- Hospices Civils de Lyon - Hôpital Louis Pradel — Bron, France (Recruiting)
- CHU Caen Normandie - Hôpital Côte de Nacre — Caen, France (Recruiting)
- CHRU Tours - Hôpital Trousseau — Chambray-lès-Tours, France (Not_yet_recruiting)
- CHU Dijon Bourgogne - Hôpital François Mitterrand — Dijon, France (Recruiting)
- CHU Grenoble Alpes - Site Nord — Grenoble, France (Recruiting)
- CHU Lille - Institut Cœur Poumon — Lille, France (Not_yet_recruiting)
- CHU Montpellier - Hôpital Arnaud de Villeneuve — Montpellier, France (Recruiting)
- CHU Nantes - Hôpital Nord Laennec — Nantes, France (Recruiting)
- Pitié Salpêtrière Hospital, Intensive Care Unit - Resuscitation — Paris, France (Recruiting)
- Pitié-Salpêtrière Hospital, Cardiovascular Surgery Intensive Care Unit — Paris, France (Recruiting)
- Hôpital Européen Georges Pompidou — Paris, France (Recruiting)
- Hôpital Bichat — Paris, France (Recruiting)
- Hôpital Bichat — Paris, France (Recruiting)
- CHU Bordeaux - Hôpital cardiologique, GH Sud Pessac — Pessac, France (Not_yet_recruiting)
- CHU Rennes, Hôpital Pontchaillou — Rennes, France (Recruiting)
- Hôpitaux universitaires de Strasbourg - Hôpital Civil — Strasbourg, France (Completed)
- CHU Toulouse - Hôpital de Rangueil — Toulouse, France (Recruiting)
- CHU Toulouse - Hôpital de Rangueil — Toulouse, France (Recruiting)
- CHRU Nancy - Hôpitaux de Brabois — Vandœuvre-lès-Nancy, France (Recruiting)
Study contacts
- Study coordinator: Adrien Bougle, PhD
- Email: Adrien.bougle@aphp.fr
- Phone: +33 1 42 16 29 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.