Extracorporeal Membrane Oxygenation ComplicationNCT05163925
EUROSETS ECMO Study in Clinical Extracorporeal Life Support Applications
An observational study of Extracorporeal Membrane Oxygenation Complication, run by Eurosets S.r.l. at 1 site in Austria.
Trial summary
This is a prospective single-center study designed for evaluation of safety and performance of the Conformitè Europëenne (CE)-marked EUROSETS ECMOLIFE SYSTEM, composed by: ECMOLIFE console, ECMO TUBING SET, ECMO OXYGENATOR and ECMOLIFE CENTRIFUGAL PUMP, HEATER COOLER (called ECMOLIFE HC) in all clinical ECLS… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- Eurosets ECMO Life System
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 10 Jan 2022to Jul 2025
- 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: Thirty consecutive patients that require ECLS and who receive the EUROSETS ECMOLIFE SYSTEM will be included. As the current study is a prospective study, choice of the device is based on surgeons' preference. ECLS usually is an unplanned procedure, post-hoc informed consent will be obtained in ECLS survivors before hospital discharge. However, when a patient clearly stated in the patient file he or she does not wish to participate in any trials, this will be honored. A screening log providing detailed information on inclusion or reasons for exclusion will be kept in record.
Who may be able to join
- Patients ≥18 years
- VA-ECLS application using the EUROSETS ECMOLIFE SYSTEM (e.g. cardiogenic shock, post cardiotomy low cardiac output syndrome, cardiac arrest, high risk percutaneous coronary intervention, eCPR)
Who cannot join
- Patients <18 years
- Pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Department of Cardiac Surgery
Vienna, 1090
Julia Riebandt, PD DDr., +43 (1) 40400 ext. 69700, julia.riebandt@meduniwien.ac.at
Julia Riebandt, PD DDr.
About this study
Official title: A Prospective Single Center Study to Evaluate Safety and Efficacy of the EUROSETS Extracorporeal Membrane Oxygenation ECMOLIFE SYSTEM in Clinical Extracorporeal Life Support Applications EUROSETS ECMO STUDY
This is a prospective single-center study designed for evaluation of safety and performance of the Conformitè Europëenne (CE)-marked EUROSETS ECMOLIFE SYSTEM, composed by: ECMOLIFE console, ECMO TUBING SET, ECMO OXYGENATOR and ECMOLIFE CENTRIFUGAL PUMP, HEATER COOLER (called ECMOLIFE HC) in all clinical ECLS applications (e.g. post-cardiotomy ECLS as well as application for cardiogenic shock after myocardial infarction or resulting from other etiologies, as well as ECLS application in patients under cardiopulmonary resuscitation (eCPR) and protected PCI) in 30 consecutive patients.
All demographic and perioperative variables (ECMOLIFE SYSTEM -related and unrelated ECLS complications, performances of the ECMOLIFE SYSTEM) will be analyzed. Surgical techniques will be recorded. Follow-up information on survival and any adverse cardiac and cerebrovascular events will be gathered routinely by outpatient clinic and telephone calls until 30 days after ECLS initiation or hospital discharge.
Read the detailed description
The prevalence of post-cardiotomy extracorporeal life support (PC-ECLS) varies between 0.6% and 3.6% of all cardiac surgical cases and represents one of the most common applications of ECLS. While a majority of patients can be weaned from cardiopulmonary bypass using inotropic and vasoactive medication, some experience refractory cardiac and/or pulmonary dysfunction requiring prolonged postoperative mechanical circulatory support. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support is a respected therapeutic option for short-term mechanical circulatory support in these critically ill patients. Indications for PC-ECLS usually include intra-operative failure to wean from cardiopulmonary bypass due to perioperative left, right or biventricular failure, or refractory cardiogenic shock/cardiac arrest in the postoperative period. While ECLS can be a life-saving therapy, it is characterized by a high mortality and morbidity due to neurologic and vascular complications amongst others.
Recently published studies reported that long-term prognosis of in-hospital survivors after ECMO support following cardiovascular surgery remains unsatisfactory, however, patients who survive have the chance to make a full recovery despite a very unfavorable prognosis without VA-ECMO. Predisposing risk factors influencing long-term survival are not fully known, however this knowledge is necessary for adequate patient selection and comprehensive decision-making prior to ECMO implantation in order to identify those patients who will truly benefit from ECMO support, since unrestrained use might disproportionately increase hospital costs and consume valuable resources.
Recently, the Extracorporeal Life Support Organization (ELSO) Registry reported a remarkable increase in the use of ECLS as a supportive therapy after cardiac surgery. However, a disappointing trend was observed with regards to the in-hospital survival rate, reaching only 15% in the latest period.
Despite this increase in use and new technological developments in this area, only a few comprehensive and dedicated reports about PC-ECLS have been presented. Nevertheless, PC-ECLS has represented the main indication for ECLS utilization and is characterized by specific aspects (duration and type of underlying disease, severity of comorbidities, indication and type of surgical procedure, modality of access and timing of implant, complication types and rates) when compared to other ECLS indication Cardiovascular diseases (CVD) are responsible for more than 4 million deaths in Europe per year. Thereby, CVD account for approximately 45% of mortality in Europe. Apart from medical and ethical aspects, this poses an economical disaster: annual costs of roughly 210 trillion USD. Among cardiovascular diseases, coronary heart disease alone is responsible for 1 million deaths per year. Myocardial infarction (MI) is often the initial manifestation of coronary heart disease, caused by myocardial ischemia and necrosis leading to an acute decrease of cardiac function. Clinically, patients in cardiogenic shock present hypotensive, unresponsive to intravenous fluid challenge and with clinical and laboratory signs of critical end organ malperfusion requiring pharmacologic and/or mechanical circulatory support.
Cardiogenic shock (CS) is the leading cause of death after myocardial infarction and occurs in 5-10% of all cases of MI. Trials such as SHOCK, IABP-SHOCK II and IMPRESS in Severe Shock all revealed a one-year mortality of approximately 50%, which reflects constant mortality rates over the last 20 years, in spite of the applied therapeutic strategies and devices.
The unacceptably high mortality and morbidity in CS is an unsolved clinical problem despite all available treatment options.
Protected PCI is the application of Mechanical Circulatory Support (MCS) during percutaneous coronary intervention in high-risk patients, meaning that in such cases MCS systems are implanted prophylactically despite hemodynamic stability to avoid deleterious complications. The overall patient condition and temporary impairment based on the acute situation of an underlying myocardial infarction or coronary ischemia, without a manifested cardiogenic shock, are potential reasons for a "prophylactic" use of MCS.
Due to the increasing complexity of procedures and patients, feasibility of such interventions is becoming more dependent on the availability of MCS, in order to guarantee hemodynamic support during revascularization. Safety and outcome of such high-risk PCIs can potentially be improved by the application of MCS and the onset of complications such as arrhythmias, hemodynamic instability and related complications during the procedure can be reduced.
In Patient without ROSC (return of spontaneous circulation) during CPR, reestablishment of circulation by emergent VA-ECLS implantation may be indicated, since eCPR is able to improve the outcome of patients after prolonged resuscitation and no-ROSC scenario.
In 2019, at the Medical University of Vienna 25 patients were treated with eCPR (approximately 9% of all CPR-patients), 20 of these patients after OHCA (out of hospital cardiac arrest). Five patients (20%) survived with a good neurologic outcome.
In the eCPR setting, time between circulatory arrest and its recovery by the ECMO circuit, is a major crucial and impacting factor as well. The ease of use in terms of device implantation would be of high importance in those cases in particular.
In summary, for every indication, devices used in ECLS require maximum reliability and must be able to generate adequate flow for full circulatory support and minimize blood trauma especially in the setting of prolonged support. Additionally, handling and monitoring should be non-complicated, the need for frequent patient transports (operating room - ICU - remote hospital facilities as required) should be taken into account. New devices should be evaluated considering these factors- next to assessment of outcome and device-related and unrelated ECLS complications.
- Being tested
- Eurosets ECMO Life System
- Keywords
- Extracorporeal Life Support Applications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eurosets ECMO Life SystemDevice
ECMOLIFE System in combination with ECMOLIFE Centrifugal Pump and ECC (extra-corporeal-circulation) Tubing Set is intended to pump blood through the extracorporeal circuit to provide extracorporeal circulation.
ECMOLIFE System must be used only in combination with ECMOLIFE Centrifugal Pump.
ECMOLIFE System is intended to operate in the following hospital environments: Operating Room, Catheter Laboratory, Emergency Room, Intensive Care Unit and during intra-hospital patient transportation from one to another Unit.
ECMOLIFE System is intended to be used by qualified healthcare professionals specifically trained in the field of extracorporeal circulation: Perfusionists (Thoracic Cardiovascular Surgery - OR), Intensivists, ICU Nurses (ICU), Emergency physicians / Intensivists (ER), Cardiologist (CathLab).
| Study group | Role | What they receive |
|---|---|---|
| EUROSETS ECMOLIFE SYSTEM | Thirty consecutive patients that require ECLS and who receive the EUROSETS ECMOLIFE SYSTEM will be included. ECMOLIFE System is a perfusion system enabling operation and monitoring of extracorporeal circulation. ECMOLIFE System operates, powers, controls and regulates ECMOLIFE Centrifugal Pump which represents the disposable blood pump. ECMOLIFE System, when used in combination with ECMOLIFE Centrifugal Pump, is suitable for full or partial cardiac, circulatory and pulmonary support.
ECMOLIFE System is composed by an active programmable console (ECMOLIFE Console), a bearing-less motor driver (ECMOLIFE Motor driver), and sensors for blood parameters detection (flow rate, pressure, temperature, SvO2 and Hb). The console is equipped with an integrated back-up which in case of primary unit failure may be operated in combination with a back-up motor driver and flowmeter (besides, the ECMOLIFE system includes an Heater cooler device). Receives: Device: Eurosets ECMO Life System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Device Malfunction
Rate of device malfunction of the EUROSETS device (ECMOLIFE console, ECMO TUBING SET, ECMO OXYGENATOR and ECMOLIFE CENTRIFUGAL PUMP, HEATER COOLER (called ECMOLIFE HC)) of total patients enrolled.
Measured: in-hospital, 30 days
Rate of device related complications
Rate of device related complications of the EUROSETS device (ECMOLIFE console, ECMO TUBING SET, ECMO OXYGENATOR and ECMOLIFE CENTRIFUGAL PUMP, HEATER COOLER (called ECMOLIFE HC)) of total patients enrolled.
Measured: in-hospital, 30 days
Secondary outcomes (2)
Rate of Mortality
Rate of in-hospital and 30 day mortality.
Measured: in-hospital, 30 days
Rate of Adverse Events
Rate of in-hospital and 30 day adverse events.
Measured: in-hospital, 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start10 Jan 2022
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eurosets S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio Petralia, Dott., Study director, Eurosets S.r.l.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163925
- Sponsor's protocol ID
- ECMO Study CIP 4.0_07.03.2025
- Status last verified
- Mar 2025
- First submitted
- 24 Sep 2021
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rastan AJ, Dege A, Mohr M, Doll N, Falk V, Walther T, Mohr FW. Early and late outcomes of 517 consecutive adult patients treated with extracorporeal membrane oxygenation for refractory postcardiotomy cardiogenic shock. J Thorac Cardiovasc Surg. 2010 Feb;139(2):302-11, 311.e1. doi: 10.1016/j.jtcvs.2009.10.043.
PubMed 20106393Elsharkawy HA, Li L, Esa WA, Sessler DI, Bashour CA. Outcome in patients who require venoarterial extracorporeal membrane oxygenation support after cardiac surgery. J Cardiothorac Vasc Anesth. 2010 Dec;24(6):946-51. doi: 10.1053/j.jvca.2010.03.020.
PubMed 20599396Whitman GJ. Extracorporeal membrane oxygenation for the treatment of postcardiotomy shock. J Thorac Cardiovasc Surg. 2017 Jan;153(1):95-101. doi: 10.1016/j.jtcvs.2016.08.024. Epub 2016 Aug 31.
PubMed 27666787Smedira NG, Blackstone EH. Postcardiotomy mechanical support: risk factors and outcomes. Ann Thorac Surg. 2001 Mar;71(3 Suppl):S60-6; discussion S82-5. doi: 10.1016/s0003-4975(00)02626-6.
PubMed 11265868Saxena P, Neal J, Joyce LD, Greason KL, Schaff HV, Guru P, Shi WY, Burkhart H, Li Z, Oliver WC, Pike RB, Haile DT, Schears GJ. Extracorporeal Membrane Oxygenation Support in Postcardiotomy Elderly Patients: The Mayo Clinic Experience. Ann Thorac Surg. 2015 Jun;99(6):2053-60. doi: 10.1016/j.athoracsur.2014.11.075. Epub 2015 Apr 10.
PubMed 25865760Fukuhara S, Takeda K, Garan AR, Kurlansky P, Hastie J, Naka Y, Takayama H. Contemporary mechanical circulatory support therapy for postcardiotomy shock. Gen Thorac Cardiovasc Surg. 2016 Apr;64(4):183-91. doi: 10.1007/s11748-016-0625-4. Epub 2016 Feb 13.
PubMed 26874519Sauer CM, Yuh DD, Bonde P. Extracorporeal membrane oxygenation use has increased by 433% in adults in the United States from 2006 to 2011. ASAIO J. 2015 Jan-Feb;61(1):31-6. doi: 10.1097/MAT.0000000000000160.
PubMed 25303799McCarthy FH, McDermott KM, Kini V, Gutsche JT, Wald JW, Xie D, Szeto WY, Bermudez CA, Atluri P, Acker MA, Desai ND. Trends in U.S. Extracorporeal Membrane Oxygenation Use and Outcomes: 2002-2012. Semin Thorac Cardiovasc Surg. 2015 Summer;27(2):81-8. doi: 10.1053/j.semtcvs.2015.07.005. Epub 2015 Jul 22.
PubMed 26686427Townsend N, Wilson L, Bhatnagar P, Wickramasinghe K, Rayner M, Nichols M. Cardiovascular disease in Europe: epidemiological update 2016. Eur Heart J. 2016 Nov 7;37(42):3232-3245. doi: 10.1093/eurheartj/ehw334. Epub 2016 Aug 14. No abstract available.
PubMed 27523477Timmis A, Townsend N, Gale C, Grobbee R, Maniadakis N, Flather M, Wilkins E, Wright L, Vos R, Bax J, Blum M, Pinto F, Vardas P; ESC Scientific Document Group. European Society of Cardiology: Cardiovascular Disease Statistics 2017. Eur Heart J. 2018 Feb 14;39(7):508-579. doi: 10.1093/eurheartj/ehx628.
PubMed 29190377Timmis A, Townsend N, Gale CP, Torbica A, Lettino M, Petersen SE, Mossialos EA, Maggioni AP, Kazakiewicz D, May HT, De Smedt D, Flather M, Zuhlke L, Beltrame JF, Huculeci R, Tavazzi L, Hindricks G, Bax J, Casadei B, Achenbach S, Wright L, Vardas P; European Society of Cardiology. European Society of Cardiology: Cardiovascular Disease Statistics 2019. Eur Heart J. 2020 Jan 1;41(1):12-85. doi: 10.1093/eurheartj/ehz859.
PubMed 31820000Harjola VP, Lassus J, Sionis A, Kober L, Tarvasmaki T, Spinar J, Parissis J, Banaszewski M, Silva-Cardoso J, Carubelli V, Di Somma S, Tolppanen H, Zeymer U, Thiele H, Nieminen MS, Mebazaa A; CardShock Study Investigators; GREAT network. Clinical picture and risk prediction of short-term mortality in cardiogenic shock. Eur J Heart Fail. 2015 May;17(5):501-9. doi: 10.1002/ejhf.260. Epub 2015 Mar 28.
PubMed 25820680van Diepen S, Katz JN, Albert NM, Henry TD, Jacobs AK, Kapur NK, Kilic A, Menon V, Ohman EM, Sweitzer NK, Thiele H, Washam JB, Cohen MG; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Quality of Care and Outcomes Research; and Mission: Lifeline. Contemporary Management of Cardiogenic Shock: A Scientific Statement From the American Heart Association. Circulation. 2017 Oct 17;136(16):e232-e268. doi: 10.1161/CIR.0000000000000525. Epub 2017 Sep 18.
PubMed 28923988Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999 Aug 26;341(9):625-34. doi: 10.1056/NEJM199908263410901.
PubMed 10460813Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Bohm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26.
PubMed 22920912
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Center Study to Evaluate Safety and Efficacy of the EUROSETS Extracorporeal Membrane Oxygenation ECMOLIFE SYSTEM in Clinical Extracorporeal Life Support Applications EUROSETS ECMO STUDY
- ClinicalTrials.gov ID
- NCT05163925
- Acronym / sponsor ID
- ECMO Study CIP 4.0_07.03.2025
- Keywords
- Extracorporeal Life Support Applications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Eurosets S.r.l.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 20 Dec 2021 (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.
This is a prospective single-center study designed for evaluation of safety and performance of the Conformitè Europëenne (CE)-marked EUROSETS ECMOLIFE SYSTEM, composed by: ECMOLIFE console, ECMO TUBING SET, ECMO OXYGENATOR and ECMOLIFE CENTRIFUGAL PUMP, HEATER COOLER (called ECMOLIFE HC) in all clinical ECLS applications (e.g. post-cardiotomy ECLS as well as application for cardiogenic shock after myocardial infarction or resulting from other etiologies, as well as ECLS application in patients under cardiopulmonary resuscitation (eCPR) and protected PCI) in 30 consecutive patients.
All demographic and perioperative variables (ECMOLIFE SYSTEM -related and unrelated ECLS complications, performances of the ECMOLIFE SYSTEM) will be analyzed. Surgical techniques will be recorded. Follow-up information on survival and any adverse cardiac and cerebrovascular events will be gathered routinely by outpatient clinic and telephone calls until 30 days after ECLS initiation or hospital discharge.
Detailed description
The prevalence of post-cardiotomy extracorporeal life support (PC-ECLS) varies between 0.6% and 3.6% of all cardiac surgical cases and represents one of the most common applications of ECLS. While a majority of patients can be weaned from cardiopulmonary bypass using inotropic and vasoactive medication, some experience refractory cardiac and/or pulmonary dysfunction requiring prolonged postoperative mechanical circulatory support. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support is a respected therapeutic option for short-term mechanical circulatory support in these critically ill patients. Indications for PC-ECLS usually include intra-operative failure to wean from cardiopulmonary bypass due to perioperative left, right or biventricular failure, or refractory cardiogenic shock/cardiac arrest in the postoperative period. While ECLS can be a life-saving therapy, it is characterized by a high mortality and morbidity due to neurologic and vascular complications amongst others.
Recently published studies reported that long-term prognosis of in-hospital survivors after ECMO support following cardiovascular surgery remains unsatisfactory, however, patients who survive have the chance to make a full recovery despite a very unfavorable prognosis without VA-ECMO. Predisposing risk factors influencing long-term survival are not fully known, however this knowledge is necessary for adequate patient selection and comprehensive decision-making prior to ECMO implantation in order to identify those patients who will truly benefit from ECMO support, since unrestrained use might disproportionately increase hospital costs and consume valuable resources.
Recently, the Extracorporeal Life Support Organization (ELSO) Registry reported a remarkable increase in the use of ECLS as a supportive therapy after cardiac surgery. However, a disappointing trend was observed with regards to the in-hospital survival rate, reaching only 15% in the latest period.
Despite this increase in use and new technological developments in this area, only a few comprehensive and dedicated reports about PC-ECLS have been presented. Nevertheless, PC-ECLS has represented the main indication for ECLS utilization and is characterized by specific aspects (duration and type of underlying disease, severity of comorbidities, indication and type of surgical procedure, modality of access and timing of implant, complication types and rates) when compared to other ECLS indication Cardiovascular diseases (CVD) are responsible for more than 4 million deaths in Europe per year. Thereby, CVD account for approximately 45% of mortality in Europe. Apart from medical and ethical aspects, this poses an economical disaster: annual costs of roughly 210 trillion USD. Among cardiovascular diseases, coronary heart disease alone is responsible for 1 million deaths per year. Myocardial infarction (MI) is often the initial manifestation of coronary heart disease, caused by myocardial ischemia and necrosis leading to an acute decrease of cardiac function. Clinically, patients in cardiogenic shock present hypotensive, unresponsive to intravenous fluid challenge and with clinical and laboratory signs of critical end organ malperfusion requiring pharmacologic and/or mechanical circulatory support.
Cardiogenic shock (CS) is the leading cause of death after myocardial infarction and occurs in 5-10% of all cases of MI. Trials such as SHOCK, IABP-SHOCK II and IMPRESS in Severe Shock all revealed a one-year mortality of approximately 50%, which reflects constant mortality rates over the last 20 years, in spite of the applied therapeutic strategies and devices.
The unacceptably high mortality and morbidity in CS is an unsolved clinical problem despite all available treatment options.
Protected PCI is the application of Mechanical Circulatory Support (MCS) during percutaneous coronary intervention in high-risk patients, meaning that in such cases MCS systems are implanted prophylactically despite hemodynamic stability to avoid deleterious complications. The overall patient condition and temporary impairment based on the acute situation of an underlying myocardial infarction or coronary ischemia, without a manifested cardiogenic shock, are potential reasons for a "prophylactic" use of MCS.
Due to the increasing complexity of procedures and patients, feasibility of such interventions is becoming more dependent on the availability of MCS, in order to guarantee hemodynamic support during revascularization. Safety and outcome of such high-risk PCIs can potentially be improved by the application of MCS and the onset of complications such as arrhythmias, hemodynamic instability and related complications during the procedure can be reduced.
In Patient without ROSC (return of spontaneous circulation) during CPR, reestablishment of circulation by emergent VA-ECLS implantation may be indicated, since eCPR is able to improve the outcome of patients after prolonged resuscitation and no-ROSC scenario.
In 2019, at the Medical University of Vienna 25 patients were treated with eCPR (approximately 9% of all CPR-patients), 20 of these patients after OHCA (out of hospital cardiac arrest). Five patients (20%) survived with a good neurologic outcome.
In the eCPR setting, time between circulatory arrest and its recovery by the ECMO circuit, is a major crucial and impacting factor as well. The ease of use in terms of device implantation would be of high importance in those cases in particular.
In summary, for every indication, devices used in ECLS require maximum reliability and must be able to generate adequate flow for full circulatory support and minimize blood trauma especially in the setting of prolonged support. Additionally, handling and monitoring should be non-complicated, the need for frequent patient transports (operating room - ICU - remote hospital facilities as required) should be taken into account. New devices should be evaluated considering these factors- next to assessment of outcome and device-related and unrelated ECLS complications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUROSETS ECMOLIFE SYSTEM | – | Device: Eurosets ECMO Life SystemThirty consecutive patients that require ECLS and who receive the EUROSETS ECMOLIFE SYSTEM will be included. ECMOLIFE System is a perfusion system enabling operation and monitoring of extracorporeal circulation. ECMOLIFE System operates, powers, controls and regulates ECMOLIFE Centrifugal Pump which represents the disposable blood pump. ECMOLIFE System, when used in combination with ECMOLIFE Centrifugal Pump, is suitable for full or partial cardiac, circulatory and pulmonary support. ECMOLIFE System is composed by an active programmable console (ECMOLIFE Console), a bearing-less motor driver (ECMOLIFE Motor driver), and sensors for blood parameters detection (flow rate, pressure, temperature, SvO2 and Hb). The console is equipped with an integrated back-up which in case of primary unit failure may be operated in combination with a back-up motor driver and flowmeter (besides, the ECMOLIFE system includes an Heater cooler device). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty consecutive patients that require ECLS and who receive the EUROSETS ECMOLIFE SYSTEM will be included. As the current study is a prospective study, choice of the device is based on surgeons' preference. ECLS usually is an unplanned procedure, post-hoc informed consent will be obtained in ECLS survivors before hospital discharge. However, when a patient clearly stated in the patient file he or she does not wish to participate in any trials, this will be honored. A screening log providing detailed information on inclusion or reasons for exclusion will be kept in record.
Key inclusion criteria (2 listed)
- Patients ≥18 years
- VA-ECLS application using the EUROSETS ECMOLIFE SYSTEM (e.g. cardiogenic shock, post cardiotomy low cardiac output syndrome, cardiac arrest, high risk percutaneous coronary intervention, eCPR)
Key exclusion criteria (2 listed)
- Patients <18 years
- Pregnant and breastfeeding women
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 |
|---|---|---|
| Eurosets ECMO Life SystemECMOLIFE System in combination with ECMOLIFE Centrifugal Pump and ECC (extra-corporeal-circulation) Tubing Set is intended to pump blood through the extracorporeal circuit to provide extracorporeal circulation. ECMOLIFE System must be used only in combination with ECMOLIFE Centrifugal Pump. ECMOLIFE System is intended to operate in the following hospital environments: Operating Room, Catheter Laboratory, Emergency Room, Intensive Care Unit and during intra-hospital patient transportation from one to another Unit. ECMOLIFE System is intended to be used by qualified healthcare professionals specifically trained in the field of extracorporeal circulation: Perfusionists (Thoracic Cardiovascular Surgery - OR), Intensivists, ICU Nurses (ICU), Emergency physicians / Intensivists (ER), Cardiologist (CathLab). | Device | EUROSETS ECMOLIFE SYSTEM |
Primary outcome
Rate of Device Malfunction
Time frame: in-hospital, 30 days
Rate of device malfunction of the EUROSETS device (ECMOLIFE console, ECMO TUBING SET, ECMO OXYGENATOR and ECMOLIFE CENTRIFUGAL PUMP, HEATER COOLER (called ECMOLIFE HC)) of total patients enrolled.
Rate of device related complications
Time frame: in-hospital, 30 days
Rate of device related complications of the EUROSETS device (ECMOLIFE console, ECMO TUBING SET, ECMO OXYGENATOR and ECMOLIFE CENTRIFUGAL PUMP, HEATER COOLER (called ECMOLIFE HC)) of total patients enrolled.
2 secondary outcomes
Rate of Mortality
Time frame: in-hospital, 30 days
Rate of Adverse Events
Time frame: in-hospital, 30 days
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 2 Jul 2025.
- Background: PubMed 20106393Rastan AJ, Dege A, Mohr M, Doll N, Falk V, Walther T, Mohr FW. Early and late outcomes of 517 consecutive adult patients treated with extracorporeal membrane oxygenation for refractory postcardiotomy cardiogenic shock. J Thorac Cardiovasc Surg. 2010 Feb;139(2):302-11, 311.e1. doi: 10.1016/j.jtcvs.2009.10.043.
- Background: PubMed 20599396Elsharkawy HA, Li L, Esa WA, Sessler DI, Bashour CA. Outcome in patients who require venoarterial extracorporeal membrane oxygenation support after cardiac surgery. J Cardiothorac Vasc Anesth. 2010 Dec;24(6):946-51. doi: 10.1053/j.jvca.2010.03.020.
- Background: PubMed 27666787Whitman GJ. Extracorporeal membrane oxygenation for the treatment of postcardiotomy shock. J Thorac Cardiovasc Surg. 2017 Jan;153(1):95-101. doi: 10.1016/j.jtcvs.2016.08.024. Epub 2016 Aug 31.
- Background: PubMed 11265868Smedira NG, Blackstone EH. Postcardiotomy mechanical support: risk factors and outcomes. Ann Thorac Surg. 2001 Mar;71(3 Suppl):S60-6; discussion S82-5. doi: 10.1016/s0003-4975(00)02626-6.
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- eurosets announces the full commercial release of its novel extracorporeal life support system ecmolifeLink provided by the sponsor.
- 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.
Antonio Petralia, Dott. study director
Eurosets S.r.l.
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 Extracorporeal Membrane Oxygenation Complication, run by Eurosets S.r.l. at 1 site in Austria.
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 2 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 2 Jul 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 Austria. 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 Antonio Petralia, Dott. (+39 0535 660370, apetralia@eurosets.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Device Malfunction (time frame: in-hospital, 30 days). The study lists 2 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 NCT05163925, which also lists 21 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 2 Jul 2025.