Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT05788120
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2023-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by ECMO-VA for Refractory Cardiogenic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D012770', 'term': 'Shock, Cardiogenic'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-04-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2023-03-06', 'studyFirstSubmitQcDate': '2023-03-27', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of atrial fibrillation in patients assisted by veno-arterial ECMO.', 'timeFrame': 'day 30', 'description': 'Atrial fibrillation will be defined as an episode of AF ≥ 30 minutes or requiring pharmacological or electrical cardioversion.'}], 'secondaryOutcomes': [{'measure': 'Number of ventricular rhythm disorders', 'timeFrame': 'day 30', 'description': 'ventricular tachycardia, ventricular fibrillation'}, {'measure': 'duration of VA ECMO support', 'timeFrame': 'day 30', 'description': 'duration of VA ECMO support'}, {'measure': 'duration of ICU stay', 'timeFrame': 'day 30', 'description': 'duration of ICU stay'}, {'measure': 'duration of mechanical ventilation', 'timeFrame': 'day 30', 'description': 'duration of mechanical ventilation'}, {'measure': 'Number of living patient', 'timeFrame': 'day 28, day 360', 'description': 'Number of living patient'}, {'measure': 'Number of thrombo-embolic complications', 'timeFrame': 'day 30', 'description': 'acute limb ischemia, circuit thrombosis, membrane thrombosis'}, {'measure': 'Number of neurological complications', 'timeFrame': 'day 30', 'description': 'ischemic and hemorrhagic stroke'}, {'measure': 'Number of bleeding complications', 'timeFrame': 'day 30', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arrhythmia', 'Veno-arterial Extra Corporeal Membrane', 'Oxygenation (VA ECMO)', 'Cardiogenic shock.'], 'conditions': ['Cardiac Rhythm Disorder']}, 'descriptionModule': {'briefSummary': '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.\n\nWhile 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.\n\nThe primary objective is to describe the incidence of supraventricular rhythm disorders in patients assisted by VA ECMO.', 'detailedDescription': "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.\n\nAtrial 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Major Patients Assisted by VA ECMO in Intensive care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient 18 years of age or older\n* Assistance with VA ECMO\n\nExclusion Criteria:\n\n* Opposition to the use of data.\n* Persons under legal protection (curators, guardianship), judicially safeguarded.\n* VA ECMO for refractory cardiac arrest.'}, 'identificationModule': {'nctId': 'NCT05788120', 'acronym': 'CAVA-ECMO', 'briefTitle': 'Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by ECMO-VA for Refractory Cardiogenic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by Extra Corporeal Membrane Oxygenation Veno-arterial (ECMO VA) for Refractory Cardiogenic Shock', 'orgStudyIdInfo': {'id': 'APHP221056'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with refractory cardiogenic shock assisted with ECMO VA', 'interventionNames': ['Other: Follow up by phone call']}], 'interventions': [{'name': 'Follow up by phone call', 'type': 'OTHER', 'description': '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)', 'armGroupLabels': ['Patients with refractory cardiogenic shock assisted with ECMO VA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuel Pr RINEAU', 'role': 'CONTACT', 'email': 'Emmanuel.Rineau@chu-angers.fr', 'phone': '+33 2 41 35 39 51'}], 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '69500', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'FELLAHI Pr Jean-Luc', 'role': 'CONTACT', 'email': 'jean-luc.fellahi@chu-lyon.fr', 'phone': '+33 4 72 11 89 33'}], 'facility': 'Hospices Civils de Lyon - Hôpital Louis Pradel', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '14000', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alina Dr DENISENKO', 'role': 'CONTACT', 'email': 'denisenko-a@chu-caen.fr'}], 'facility': 'CHU Caen Normandie - Hôpital Côte de Nacre', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '37170', 'city': 'Chambray-lès-Tours', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sabrina Dr CHETOUNE', 'role': 'CONTACT', 'email': 'S.CHETOUANE@chu-tours.fr', 'phone': '+33 2 47 47 47 47'}], 'facility': 'CHRU Tours - Hôpital Trousseau', 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '21000', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre-Grégoire Pr GUINOT', 'role': 'CONTACT', 'email': 'guinotpierregregoire@gmail.com'}], 'facility': 'CHU Dijon Bourgogne - Hôpital François Mitterrand', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38700', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandre Dr BEHOUCHE', 'role': 'CONTACT', 'email': 'ABehouche@chu-grenoble.fr'}], 'facility': 'CHU Grenoble Alpes - Site Nord', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59000', 'city': 'Lille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benoit BRASSART', 'role': 'CONTACT', 'email': 'Benoit.BRASSART@chu-lille.fr', 'phone': '+33 3 20 44 59 62'}], 'facility': 'CHU Lille - Institut Cœur Poumon', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Phillipe Dr GAUDARD', 'role': 'CONTACT', 'email': 'p-gaudard@chu-montpellier.fr'}], 'facility': 'CHU Montpellier - Hôpital Arnaud de Villeneuve', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44000', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bertrand Pr Rozec', 'role': 'CONTACT', 'email': 'bertrand.rozec@chu-nantes.fr', 'phone': '+33 2 40 16 53 04'}], 'facility': 'CHU Nantes - Hôpital Nord Laennec', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alain Pr COMBES', 'role': 'CONTACT', 'email': 'alain.combes@aphp.fr', 'phone': '+33 1 42 16 38 18'}], 'facility': 'Pitié Salpêtrière Hospital, Intensive Care Unit - Resuscitation', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Adrien Pr Bouglé', 'role': 'CONTACT', 'email': 'adrien.bougle@aphp.fr', 'phone': '+33 1 42 16 29 91'}], 'facility': 'Pitié-Salpêtrière Hospital, Cardiovascular Surgery Intensive Care Unit', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hélène Dr NOUGUE', 'role': 'CONTACT', 'email': 'helene.nougue@aphp.fr', 'phone': '+33 1 56 09 25 94'}], 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie Dr PROVENCHERE', 'role': 'CONTACT', 'email': 'sophie.provenchere@aphp.fr', 'phone': '+33 1 40 25 83 55'}], 'facility': 'Hôpital Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romain Pr SONNEVILLE', 'role': 'CONTACT', 'email': 'romain.sonneville@aphp.fr', 'phone': '+33 1 40 25 61 39'}], 'facility': 'Hôpital Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33600', 'city': 'Pessac', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine Dr BEURTON', 'role': 'CONTACT', 'email': 'antoine.beurton@chu-bordeaux.fr', 'phone': '+33 5 56 79 56 79'}], 'facility': 'CHU Bordeaux - Hôpital cardiologique, GH Sud Pessac', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '35000', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas Dr NESSELER', 'role': 'CONTACT', 'email': 'nicolas.nesseler@chu-rennes.fr'}], 'facility': 'CHU Rennes, Hôpital Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67000', 'city': 'Strasbourg', 'status': 'COMPLETED', 'country': 'France', 'facility': 'Hôpitaux universitaires de Strasbourg - Hôpital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31300', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fanny Dr BOUNES-VARDON', 'role': 'CONTACT', 'email': 'bounes.f@chu-toulouse.fr ; vardon.f@chu-toulouse.fr', 'phone': '+33 5 61 32 27 99'}], 'facility': 'CHU Toulouse - Hôpital de Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31300', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François Dr LABASTE', 'role': 'CONTACT', 'email': 'labaste.f@chu-toulouse.fr', 'phone': '+33 5 61 32 28 22'}], 'facility': 'CHU Toulouse - Hôpital de Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Phillipe Pr GUERCI', 'role': 'CONTACT', 'email': 'p.guerci@chru-nancy.fr', 'phone': '+33 3 83 15 79 95'}], 'facility': 'CHRU Nancy - Hôpitaux de Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Adrien Bougle, PhD', 'role': 'CONTACT', 'email': 'Adrien.bougle@aphp.fr', 'phone': '+33 1 42 16 29 91'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor', 'ipdSharing': 'YES', 'description': "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.\n\nConsultation 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.", 'accessCriteria': 'Researchers who provide a methodologically sound proposal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}