Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 4:46 PM
Study NCT ID:
NCT06766006
Status:
RECRUITING
Last Update Posted:
2025-01-09
First Post:
2023-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ECMO LEft Ventricle UNloading Strategy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}, {'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004343', 'term': 'Drug Implants'}], 'ancestors': [{'id': 'D003692', 'term': 'Delayed-Action Preparations'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-03', 'studyFirstSubmitDate': '2023-12-14', 'studyFirstSubmitQcDate': '2025-01-03', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-diastolic diameter (mm)', 'timeFrame': '12 hours after the unloading technique implementation', 'description': 'LV end-diastolic diameter (mm)'}, {'measure': 'Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-diastolic volume (ml)', 'timeFrame': '12 hours after the unloading technique implementation', 'description': 'LV end-diastolic volume (ml)'}, {'measure': 'Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-systolic diameter (mm)', 'timeFrame': '12 hours after the unloading technique implementation', 'description': 'LV end-systolic diameter (mm)'}, {'measure': 'Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-systolic volume(ml)', 'timeFrame': '12 hours after the unloading technique implementation', 'description': 'LV end-systolic volume(ml)'}, {'measure': 'Unloading Effectiveness, Quantitative echocardiographic parameters, LA volume (ml)', 'timeFrame': '12 hours after the unloading technique implementation', 'description': 'LA volume (ml)'}, {'measure': "Unloading Effectiveness, Quantitative echocardiographic parameters, E/E' septal and lateral (ratio, no unit of measurement )", 'timeFrame': '12 hours after the unloading technique implementation', 'description': "E/E' septal and lateral (ratio, no unit of measurement )"}, {'measure': 'Unloading Effectiveness, Quantitative echocardiographic parameters, Systolic pulmonary artery pressure (mmHg)', 'timeFrame': '12 hours after the unloading technique implementation', 'description': 'Systolic pulmonary artery pressure (mmHg)'}], 'primaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': 'Day 30', 'description': 'Death during hospital stay'}, {'measure': 'Overload detection, Echocardiographic parameters', 'timeFrame': 'Within 12 hours before the applied unloading technique', 'description': 'Presence of left ventricle (LV) overload (defined as: aortic valve opening impairment and/or smoke like effect and/or LA distension and/or LV distension).\n\nThe aforementioned criteria are defined as follows:\n\n* Aortic valve opening impairment: Aortic valve does not open every beat.\n* Smoke like effect: spontaneous echo contrast inside left ventricle chamber.\n* Left Atrium (LA) distension: male/female LA volume/body surface area (BSA)\\>=34 or increase\\>15%\n* LV distension: LV end-diastolic volume (ml) \\>150 ml, male; female LV end-diastolic volume (ml) \\>106 ml or increase\\>15%'}, {'measure': 'Unloading effectiveness, Echocardiographic parameters', 'timeFrame': '12 hours after the unloading technique implementation', 'description': "Echocardiographic qualitative parameters:\n\n* aortic valve opening (yes/no)\n* smoke like effect (yes/no)\n* LA distension (yes/no)\n* LV distension (yes/no)\n* inferior vena cava collapse/dilation (yes/no)\n* grade of mitral regurgitation (mild/moderatre/severe)\n\nEchocardiographic quantitative parameters:\n\n* LV end-diastolic diameter (mm)\n* LV end-diastolicvolume (ml)\n* LV end-systolic diameter (mm)\n* LV end-systolic volume(ml)\n* LA volume (ml)\n* E/E' septal and lateral (ratio, no unit of measurement )\n* systolic pulmonary artery pressure (mmHg)"}], 'secondaryOutcomes': [{'measure': 'Unloading Effectiveness, Qualitative echocardiographic parameters', 'timeFrame': '12 hours after the unloading technique implementation', 'description': 'Unloading effectiveness, qualitative evaluation (yes/no) ( any of the following criteria: restored aortic valve opening (yes/no) and/or solved smoke like effect (yes/no) and/or reduced LA distension (yes/no) and/or reduced LV distension (yes/no) and/or decreased grade of mitral regurgitation)'}, {'measure': 'Major adverse events', 'timeFrame': 'Day 30', 'description': 'Cerebral injury (stroke, transitory ischemic attack, intracranial hemorrhage and seizures by electroencephalogram), acute kidney injury requiring continuous renal replacement therapy, hemolysis (defined as increased free hemoglobin level, peripheral vascular damage, infections (defined as positive bacterial, fungal or viral culture or polymerase chain reaction test), coagulation disorders (either thrombosis or hemorrhage) and ECLS failure (pump or oxygenator failure, or both), liver and kidney organ function.'}, {'measure': 'Left Ventricular functional status', 'timeFrame': 'Day 30', 'description': 'Left ventricle Ejection fraction (%)'}, {'measure': 'LVAD Implementation', 'timeFrame': 'Day 30', 'description': 'LVAD implant'}, {'measure': 'Heart transplant', 'timeFrame': 'Day 30', 'description': 'Heart transplant'}, {'measure': 'Neurological status at discharge', 'timeFrame': 'Day 30', 'description': 'Cerebral Performance Category (CPC)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extracorporeal Membrane Oxygenation', 'Left ventricle unloading', 'Cardiogenic shock', 'Cardiac Arrest', 'Mechanical Circulatory Supports'], 'conditions': ['Shock, Cardiogenic', 'Cardiac Arrest', 'Extracorporeal Membrane Oxygenation Complication']}, 'referencesModule': {'references': [{'pmid': '29312691', 'type': 'BACKGROUND', 'citation': 'Camboni D, Schmid C. To vent or not on veno-arterial extracorporeal membrane oxygenation, does it improve myocardial recovery and outcome? J Thorac Dis. 2017 Dec;9(12):4915-4918. doi: 10.21037/jtd.2017.11.98. No abstract available.'}, {'pmid': '33032450', 'type': 'BACKGROUND', 'citation': 'Schrage B, Becher PM, Bernhardt A, Bezerra H, Blankenberg S, Brunner S, Colson P, Cudemus Deseda G, Dabboura S, Eckner D, Eden M, Eitel I, Frank D, Frey N, Funamoto M, Gossling A, Graf T, Hagl C, Kirchhof P, Kupka D, Landmesser U, Lipinski J, Lopes M, Majunke N, Maniuc O, McGrath D, Mobius-Winkler S, Morrow DA, Mourad M, Noel C, Nordbeck P, Orban M, Pappalardo F, Patel SM, Pauschinger M, Pazzanese V, Reichenspurner H, Sandri M, Schulze PC, H G Schwinger R, Sinning JM, Aksoy A, Skurk C, Szczanowicz L, Thiele H, Tietz F, Varshney A, Wechsler L, Westermann D. Left Ventricular Unloading Is Associated With Lower Mortality in Patients With Cardiogenic Shock Treated With Venoarterial Extracorporeal Membrane Oxygenation: Results From an International, Multicenter Cohort Study. Circulation. 2020 Dec;142(22):2095-2106. doi: 10.1161/CIRCULATIONAHA.120.048792. Epub 2020 Oct 9.'}, {'pmid': '22819880', 'type': 'BACKGROUND', 'citation': 'Haneya A, Philipp A, Diez C, Schopka S, Bein T, Zimmermann M, Lubnow M, Luchner A, Agha A, Hilker M, Hirt S, Schmid C, Muller T. A 5-year experience with cardiopulmonary resuscitation using extracorporeal life support in non-postcardiotomy patients with cardiac arrest. Resuscitation. 2012 Nov;83(11):1331-7. doi: 10.1016/j.resuscitation.2012.07.009. Epub 2012 Jul 20.'}, {'pmid': '22555310', 'type': 'BACKGROUND', 'citation': 'Arlt M, Philipp A, Voelkel S, Schopka S, Husser O, Hengstenberg C, Schmid C, Hilker M. Early experiences with miniaturized extracorporeal life-support in the catheterization laboratory. Eur J Cardiothorac Surg. 2012 Nov;42(5):858-63. doi: 10.1093/ejcts/ezs176. Epub 2012 May 3.'}, {'pmid': '30112975', 'type': 'BACKGROUND', 'citation': 'Donker DW, Brodie D, Henriques JPS, Broome M. Left ventricular unloading during veno-arterial ECMO: a review of percutaneous and surgical unloading interventions. Perfusion. 2019 Mar;34(2):98-105. doi: 10.1177/0267659118794112. Epub 2018 Aug 16.'}, {'pmid': '33642170', 'type': 'BACKGROUND', 'citation': 'Meani P, Lorusso R, Pappalardo F. ECPella: Concept, Physiology and Clinical Applications. J Cardiothorac Vasc Anesth. 2022 Feb;36(2):557-566. doi: 10.1053/j.jvca.2021.01.056. Epub 2021 Feb 6.'}, {'pmid': '28470925', 'type': 'BACKGROUND', 'citation': 'Meani P, Gelsomino S, Natour E, Johnson DM, Rocca HB, Pappalardo F, Bidar E, Makhoul M, Raffa G, Heuts S, Lozekoot P, Kats S, Sluijpers N, Schreurs R, Delnoij T, Montalti A, Sels JW, van de Poll M, Roekaerts P, Poels T, Korver E, Babar Z, Maessen J, Lorusso R. Modalities and Effects of Left Ventricle Unloading on Extracorporeal Life support: a Review of the Current Literature. Eur J Heart Fail. 2017 May;19 Suppl 2:84-91. doi: 10.1002/ejhf.850.'}, {'pmid': '30024298', 'type': 'BACKGROUND', 'citation': 'Meani P, Delnoij T, Raffa GM, Morici N, Viola G, Sacco A, Oliva F, Heuts S, Sels JW, Driessen R, Roekaerts P, Gilbers M, Bidar E, Schreurs R, Natour E, Veenstra L, Kats S, Maessen J, Lorusso R. Protracted aortic valve closure during peripheral veno-arterial extracorporeal life support: is intra-aortic balloon pump an effective solution? Perfusion. 2019 Jan;34(1):35-41. doi: 10.1177/0267659118787426. Epub 2018 Jul 19.'}, {'pmid': '29489461', 'type': 'BACKGROUND', 'citation': 'Patel SM, Lipinski J, Al-Kindi SG, Patel T, Saric P, Li J, Nadeem F, Ladas T, Alaiti A, Phillips A, Medalion B, Deo S, Elgudin Y, Costa MA, Osman MN, Attizzani GF, Oliveira GH, Sareyyupoglu B, Bezerra HG. Simultaneous Venoarterial Extracorporeal Membrane Oxygenation and Percutaneous Left Ventricular Decompression Therapy with Impella Is Associated with Improved Outcomes in Refractory Cardiogenic Shock. ASAIO J. 2019 Jan;65(1):21-28. doi: 10.1097/MAT.0000000000000767.'}, {'pmid': '35361346', 'type': 'BACKGROUND', 'citation': 'Grandin EW, Nunez JI, Willar B, Kennedy K, Rycus P, Tonna JE, Kapur NK, Shaefi S, Garan AR. Mechanical Left Ventricular Unloading in Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation. J Am Coll Cardiol. 2022 Apr 5;79(13):1239-1250. doi: 10.1016/j.jacc.2022.01.032.'}, {'pmid': '30632894', 'type': 'BACKGROUND', 'citation': 'Raffa GM, Kowalewski M, Meani P, Follis F, Martucci G, Arcadipane A, Pilato M, Maessen J, Lorusso R; ECMO in TAVI Investigators Group (ETIG). In-hospital outcomes after emergency or prophylactic veno-arterial extracorporeal membrane oxygenation during transcatheter aortic valve implantation: a comprehensive review of the literature. Perfusion. 2019 Jul;34(5):354-363. doi: 10.1177/0267659118816555. Epub 2019 Jan 11.'}, {'pmid': '27709750', 'type': 'BACKGROUND', 'citation': 'Pappalardo F, Schulte C, Pieri M, Schrage B, Contri R, Soeffker G, Greco T, Lembo R, Mullerleile K, Colombo A, Sydow K, De Bonis M, Wagner F, Reichenspurner H, Blankenberg S, Zangrillo A, Westermann D. Concomitant implantation of Impella(R) on top of veno-arterial extracorporeal membrane oxygenation may improve survival of patients with cardiogenic shock. Eur J Heart Fail. 2017 Mar;19(3):404-412. doi: 10.1002/ejhf.668. Epub 2016 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'The present study is an International multicentric prospective observational cohort study. This will be an international research campaign to prospectively collect and analyze clinical data of all VA ECLS patients admitted to participating ICUs with a focus on LV venting modalities. The aims of the study are:\n\n* To investigate the meaning of LV overload during veno-arterial (VA) extracorporeal life support;\n* To extensively describe the left ventricular (LV) unloading strategy during VA extracorporeal life support in a large prospective international cohort.\n* To compare different strategies to unload the left ventricular in terms of efficacy and outcomes;', 'detailedDescription': 'Cardiogenic shock and cardiac arrest are among the most lethal manifestations of acute cardiovascular disease, both burdened by extremely high in-hospital mortality rates. Extracorporeal life support is increasingly used either in adults or children with acutely impaired cardiac function refractory to conventional medical management, mainly in profound cardiogenic shock and refractory cardiac arrest. Veno-arterial extracorporeal life support works as a partial cardiopulmonary bypass draining the venous circulation directly into the systemic circulation. Veno-arterial extracorporeal life support provides biventricular support and provides respiratory gas exchange. One of the most important issues occurring during veno-arterial extracorporeal life support is the effect of the retrograde aortic flow which causes a marked increase in the left ventricular afterload with detrimental effects on myocardial performance. Left ventricular overload increases wall stress and myocardial oxygen consumption, jeopardizing ventricular recovery. Nowadays, different techniques are available for unloading the left chambers. However, despite the increasing worldwide experience with extracorporeal life support and the increased knowledge on the benefits of left ventricular unloading, the best veno-arterial extracorporeal life support configuration to achieve hemodynamic support, myocardial recovery, and left ventricular unloading, is still a matter of debate.\n\nThis is a prospective clinical study which is observational. The aims of the study are:\n\n* To extensively describe the left ventricular unloading strategy during veno-arterial extracorporeal life support in a large prospective international cohort, providing detailed information on indications, timing, type and modality among a wide spectrum of clinical conditions\n* To compare different strategies to unload the left ventricular in terms of efficacy and outcomes\n* To provide a common definition of left ventricular overload by collecting clinical, hemodynamic data and radiological information before and after unloading.\n\nDemographics, clinical, instrumental and laboratory data prior and post implantation of veno-arterial extracorporeal life support will be collected. No interventions on top on the ones necessary as a standard of care will be taken.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients affected by cardiogenic shock or cardiac arrest independent of etiology supported with VA ECLS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing VA ECLS will be enrolled.\n\nExclusion Criteria:\n\n* Patients without VA ECMO will not be considered'}, 'identificationModule': {'nctId': 'NCT06766006', 'acronym': 'ECMOLENS', 'briefTitle': 'ECMO LEft Ventricle UNloading Strategy', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'A Multicentric Left Ventricular Venting Strategy Comparison in Patients Receiving Venoarterial Extracorporeal Life Support', 'orgStudyIdInfo': {'id': '2023-0112'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VA ECLS patients', 'description': 'All patients undergoing VA ECLS will be enrolled. Patients without VA ECLS will not be considered. Centers will follow their standard protocols for the management of patients on VA ECLS.', 'interventionNames': ['Procedure: Venoarterial extracorporeal life support (VA ECLS) implant']}], 'interventions': [{'name': 'Venoarterial extracorporeal life support (VA ECLS) implant', 'type': 'PROCEDURE', 'description': 'Implantation of venoarterial extracorporeal life support implant for refractory cardiogenic shock or cardiac arrest of any cause.', 'armGroupLabels': ['VA ECLS patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Paolo Meani, MD, PhD', 'role': 'CONTACT', 'email': 'paolo.meani@mumc.nl', 'phone': '+393392944331'}, {'name': 'Paolo Meani, MD,PhD', 'role': 'CONTACT', 'email': 'paolo.meani@mumc.nl'}, {'name': 'Paolo Meani, MD,PhD', 'role': 'CONTACT'}], 'facility': 'Maastricht UMC', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'centralContacts': [{'name': 'Paolo Meani, MD, PhD', 'role': 'CONTACT', 'email': 'paolo.meani@mumc.nl', 'phone': '43 38811067', 'phoneExt': '+31'}, {'name': 'Roberto Lorusso, MD,PhD', 'role': 'CONTACT', 'email': 'roberto.lorussobs@gmail.com', 'phone': '43 38811067', 'phoneExt': '+31'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'IRCCS Policlinico S. Donato', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}