Shock, CardiogenicECMOLENSNCT06766006
ECMO LEft Ventricle UNloading Strategy
An observational study of Shock, Cardiogenic and Cardiac Arrest, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 day to 80 years
- Conditions the study is for
- Shock, Cardiogenic, Cardiac Arrest, Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- Venoarterial extracorporeal life support (VA ECLS) implant
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2024to 1 Apr 2026
- 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 1 day to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients affected by cardiogenic shock or cardiac arrest independent of etiology supported with VA ECLS.
Who may be able to join
- All patients undergoing VA ECLS will be enrolled.
Who cannot join
- Patients without VA ECMO will not be considered
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht UMC
Maastricht
Paolo Meani, MD, PhD, +393392944331, paolo.meani@mumc.nl
Paolo Meani, MD,PhD, paolo.meani@mumc.nl
About this study
Official title: A Multicentric Left Ventricular Venting Strategy Comparison in Patients Receiving Venoarterial Extracorporeal Life Support
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:
- To investigate the meaning of LV overload during veno-arterial (VA) extracorporeal life support;
- To extensively describe the left ventricular (LV) unloading strategy during VA extracorporeal life support in a large prospective international cohort.
- To compare different strategies to unload the left ventricular in terms of efficacy and outcomes;
Read the detailed description
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.
This is a prospective clinical study which is observational. The aims of the study are:
- 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
- To compare different strategies to unload the left ventricular in terms of efficacy and outcomes
- To provide a common definition of left ventricular overload by collecting clinical, hemodynamic data and radiological information before and after unloading.
Demographics, 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.
- Being tested
- Venoarterial extracorporeal life support (VA ECLS) implant
- Keywords
- Extracorporeal Membrane Oxygenation, Left ventricle unloading, Cardiogenic shock, Cardiac Arrest, Mechanical Circulatory Supports
- Medical subject headings
- Shock, Cardiogenic, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venoarterial extracorporeal life support (VA ECLS) implantProcedure or surgery
Implantation of venoarterial extracorporeal life support implant for refractory cardiogenic shock or cardiac arrest of any cause.
| Study group | Role | What they receive |
|---|---|---|
| VA ECLS patients | 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. Receives: Procedure: Venoarterial extracorporeal life support (VA ECLS) implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Death during hospital stay
Measured: Day 30
Overload detection, Echocardiographic parameters
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).
The aforementioned criteria are defined as follows:
- Aortic valve opening impairment: Aortic valve does not open every beat.
- Smoke like effect: spontaneous echo contrast inside left ventricle chamber.
- Left Atrium (LA) distension: male/female LA volume/body surface area (BSA)>=34 or increase>15%
- LV distension: LV end-diastolic volume (ml) >150 ml, male; female LV end-diastolic volume (ml) >106 ml or increase>15%
Measured: Within 12 hours before the applied unloading technique
Unloading effectiveness, Echocardiographic parameters
Echocardiographic qualitative parameters:
- aortic valve opening (yes/no)
- smoke like effect (yes/no)
- LA distension (yes/no)
- LV distension (yes/no)
- inferior vena cava collapse/dilation (yes/no)
- grade of mitral regurgitation (mild/moderatre/severe)
Echocardiographic quantitative parameters:
- LV end-diastolic diameter (mm)
- LV end-diastolicvolume (ml)
- LV end-systolic diameter (mm)
- LV end-systolic volume(ml)
- LA volume (ml)
- E/E' septal and lateral (ratio, no unit of measurement )
- systolic pulmonary artery pressure (mmHg)
Measured: 12 hours after the unloading technique implementation
Secondary outcomes (6)
Unloading Effectiveness, Qualitative echocardiographic parameters
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)
Measured: 12 hours after the unloading technique implementation
Major adverse events
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.
Measured: Day 30
Left Ventricular functional status
Left ventricle Ejection fraction (%)
Measured: Day 30
LVAD Implementation
LVAD implant
Measured: Day 30
Heart transplant
Heart transplant
Measured: Day 30
Neurological status at discharge
Cerebral Performance Category (CPC)
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 posted9 Jan 2025
- Study start1 Apr 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Shock, CardiogenicStudies of the same condition, open and under way.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Policlinico S. Donato
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766006
- Sponsor's protocol ID
- 2023-0112
- Acronym
- ECMOLENS
- Status last verified
- Jan 2025
- First submitted
- 14 Dec 2023
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29312691Schrage 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.
PubMed 33032450Haneya 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.
PubMed 22819880Arlt 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.
PubMed 22555310Donker 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.
PubMed 30112975Meani 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.
PubMed 33642170Meani 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.
PubMed 28470925Meani 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.
PubMed 30024298Patel 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.
PubMed 29489461Grandin 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.
PubMed 35361346Raffa 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.
PubMed 30632894Pappalardo 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.
PubMed 27709750
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric Left Ventricular Venting Strategy Comparison in Patients Receiving Venoarterial Extracorporeal Life Support
- ClinicalTrials.gov ID
- NCT06766006
- Acronym / sponsor ID
- ECMOLENS / 2023-0112
- Keywords
- Extracorporeal Membrane Oxygenation, Left ventricle unloading, Cardiogenic shock, Cardiac Arrest, Mechanical Circulatory Supports
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- IRCCS Policlinico S. Donato
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 9 Jan 2025 (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.
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:
- To investigate the meaning of LV overload during veno-arterial (VA) extracorporeal life support;
- To extensively describe the left ventricular (LV) unloading strategy during VA extracorporeal life support in a large prospective international cohort.
- To compare different strategies to unload the left ventricular in terms of efficacy and outcomes;
Detailed description
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.
This is a prospective clinical study which is observational. The aims of the study are:
- 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
- To compare different strategies to unload the left ventricular in terms of efficacy and outcomes
- To provide a common definition of left ventricular overload by collecting clinical, hemodynamic data and radiological information before and after unloading.
Demographics, 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VA ECLS patients | – | Procedure: Venoarterial extracorporeal life support (VA ECLS) implantAll 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. |
Who may qualify
- Ages
- 1 day to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients affected by cardiogenic shock or cardiac arrest independent of etiology supported with VA ECLS.
Key inclusion criteria (1 listed)
- All patients undergoing VA ECLS will be enrolled.
Key exclusion criteria (1 listed)
- Patients without VA ECMO will not be considered
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 |
|---|---|---|
| Venoarterial extracorporeal life support (VA ECLS) implantImplantation of venoarterial extracorporeal life support implant for refractory cardiogenic shock or cardiac arrest of any cause. | Procedure or surgery | VA ECLS patients |
Primary outcome
In-hospital mortality
Time frame: Day 30
Death during hospital stay
Overload detection, Echocardiographic parameters
Time frame: Within 12 hours before the applied unloading technique
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). The aforementioned criteria are defined as follows: * Aortic valve opening impairment: Aortic valve does not open every beat. * Smoke like effect: spontaneous echo contrast inside left ventricle chamber. * Left Atrium (LA) distension: male/female LA volume/body surface area (BSA)>=34 or increase>15% * LV distension: LV end-diastolic volume (ml) >150 ml, male; female LV end-diastolic volume (ml) >106 ml or increase>15%
Unloading effectiveness, Echocardiographic parameters
Time frame: 12 hours after the unloading technique implementation
Echocardiographic qualitative parameters: * aortic valve opening (yes/no) * smoke like effect (yes/no) * LA distension (yes/no) * LV distension (yes/no) * inferior vena cava collapse/dilation (yes/no) * grade of mitral regurgitation (mild/moderatre/severe) Echocardiographic quantitative parameters: * LV end-diastolic diameter (mm) * LV end-diastolicvolume (ml) * LV end-systolic diameter (mm) * LV end-systolic volume(ml) * LA volume (ml) * E/E' septal and lateral (ratio, no unit of measurement ) * systolic pulmonary artery pressure (mmHg)
6 secondary outcomes
Unloading Effectiveness, Qualitative echocardiographic parameters
Time frame: 12 hours after the unloading technique implementation
Major adverse events
Time frame: Day 30
Left Ventricular functional status
Time frame: Day 30
LVAD Implementation
Time frame: Day 30
Heart transplant
Time frame: Day 30
Neurological status at discharge
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 9 Jan 2025.
- Background: PubMed 29312691Camboni 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.
- Background: PubMed 33032450Schrage 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.
- Background: PubMed 22819880Haneya 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.
- Background: PubMed 22555310Arlt 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.
- Background: PubMed 30112975Donker 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.
- Background: PubMed 33642170Meani 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.
- Background: PubMed 28470925Meani 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.
- Background: PubMed 30024298Meani 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.
- Background: PubMed 29489461Patel 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.
- Background: PubMed 35361346Grandin 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.
- Background: PubMed 30632894Raffa 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.
- Background: PubMed 27709750Pappalardo 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.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, Cardiogenic and Cardiac Arrest, run by Maastricht University Medical Center at 1 site in Netherlands.
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 1 inclusion and 1 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 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 Paolo Meani, MD, PhD (43 38811067 ext. +31, paolo.meani@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: Day 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06766006, which also lists 12 linked publications.
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 9 Jan 2025.