Ignite Creation Date:
2024-05-06 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05163925
Status:
RECRUITING
Last Update Posted:
2022-01-25
First Post:
2021-09-24
Brief Title:
EUROSETS ECMO Study in Clinical Extracorporeal Life Support Applications
Sponsor:
Eurosets Srl
Organization:
Eurosets Srl
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 applications eg 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
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 06 and 36 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 andor 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 shockcardiac 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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None