Cardiogenic ShockIMPACTNCT06644963
IMPELLA, Complications and Tolerance
An observational study of Cardiogenic Shock, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Myocardial infarction complicated by cardiogenic shock (AMICS) is associated with high morbidity and mortality, and devices like Impella® CP and Impella 5.0-5.5 are often used for hemodynamic support, either alone or combined with veno-arterial ECMO (ECMELLA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Impella (5, 5.5 or CP)
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2010to 30 Jan 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: All adult patients admitted for cardiogenic shock supported by Impella (5, 5.5 or CP) between January 1, 2010, and December 31, 2022 (as an isolated circulatory support or combined with others Temporary Mechanical Circulatory Support)
Who may be able to join
- Adult patients admitted for cardiogenic shock supported by Impella (5, 5.5 or CP) between January 1, 2010, and December 31, 2022 (as an isolated circulatory support or combined with others Temporary Mechanical Circulatory Support)
Who cannot join
- Absence of Impella
- Impella 2.5
- Impella RP (right)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Montpellier university hospital
Montpellier, 34295
Aurore UGHETTO, MD, 0033622054893, a-ughetto@chu-montpellier.fr
Clément DELMAS, MD, PhD, clement23185@hotmail.fr
About this study
Myocardial infarction complicated by cardiogenic shock (AMICS) is associated with high morbidity and mortality, and devices like Impella® CP and Impella 5.0-5.5 are often used for hemodynamic support, either alone or combined with veno-arterial ECMO (ECMELLA). While recent studies suggest improved survival with Impella® in cardiogenic shock, complications remain common, particularly due to deep arterial access and the need for anticoagulation. Hemocompatibility-related adverse events (HRAEs) such as ischemia, bleeding (44%), hemolysis (32%), and stroke (13%) frequently occur. Achieving hemocompatibility between the patient's blood and the device is challenging, as pump flow, anticoagulation, and patient factors contribute to both thrombotic and hemorrhagic complications. Despite advances, further research is required to better understand and reduce these risks in clinical practice.
Read the detailed description
Myocardial infarction complicated by cardiogenic shock (AMICS) is associated with high rates of morbidity and mortality. To provide hemodynamic support in these cases, intravascular microaxial left ventricular assist devices, such as Impella® CP and Impella 5.0-5.5, are frequently used, either alone in cardiogenic shock (CS) or in combination with veno-arterial ECMO (known as ECMELLA) for left ventricular unloading. Recent observational studies and randomized controlled trials have suggested improved survival rates with the use of Impella® in cardiogenic shock patients.
Despite the growing use of these devices, complications in clinical practice remain frequent. Due to the need for deep arterial access (14F for Impella CP and 21F for Impella 5.0) via femoral or axillary routes, as well as the necessity of anticoagulation, hemocompatibility-related adverse events (HRAEs) such as ischemic complications and bleeding are common, occurring in 18% and 44% of patients, respectively. Hemolysis has been reported in up to 32% of cases, while stroke affects up to 13%. Other less frequent complications include device deployment issues, pump thrombosis, implant site infections, and sepsis, all contributing to increased healthcare costs.
Achieving hemocompatibility between the patient's blood and the device remains a significant challenge despite advances in Impella technology. Balancing prothrombotic and prohemorrhagic forces at the blood/device interface is complex. This interface activates the coagulation cascade, generating a prothrombotic state, damaging von Willebrand multimers, and leading to hemolysis. The interplay of pump flow, pump speed, patient risk factors, and clinical management (anticoagulation) further complicates hemocompatibility, often resulting in thrombotic or bleeding events such as hemorrhagic stroke, circuit clots, or ischemic stroke.
Although the occurrence of HRAEs is well documented, particularly in the case of severe events like stroke, there is still an incomplete understanding of the factors driving these complications in modern clinical practice. Further research is needed to better delineate the risk factors and improve outcomes for patients receiving Impella support.
- Conditions
- Cardiogenic Shock
- Being tested
- Impella (5, 5.5 or CP)
- Keywords
- Impella, pVAD, Bleeding, Thrombosis, hemocompatibily related adverse events
- Medical subject headings
- Shock, Cardiogenic, Hemorrhage, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impella (5, 5.5 or CP)Device
Impella (5, 5.5 or CP) as an isolated circulatory support or combined with others Temporary Mechanical Circulatory Support
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemocompatibility related adverse events (HRAEs)
Incidence of HRAEs with Impella (CP and/or 5 - 5.5) : Bleeding events (BARC >3b) and Thrombosis events ( ischemic stroke + pump thrombosis)
Measured: From start of hospitalization until hospital discharge, assessed up to 3 month
Secondary outcomes (5)
Early mortality
In-hospital all-cause mortality
Measured: From start of hospitalization until hospital discharge, assessed up to 3 month
Adverse events related to Impella devices
Hemolysis; Bacteremia; Infection of the device insertion site or the device itself
Measured: From start of hospitalization until hospital discharge assessed up to 3 month
Duration of mechanical ventilation
Total duration of invasive mechanical ventilation
Measured: From start of hospitalization until hospital discharge, assessed up to 3 month
Lengh of stay
Total and in intensive care unit lenght of stay
Measured: From start of hospitalization until hospital discharge, assessed up to 3 month
Cardiac long-term project
Rate and % of patients with myocardial recovery, ventricular assist device or/and heart transplantation
Measured: From start of hospitalization until hospital discharge assessed up to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Jan 2010
- Primary completion1 Jan 2023
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies 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
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurore UGHETTO, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644963
- Sponsor's protocol ID
- 2024-08-120
- Acronym
- IMPACT
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Van Edom CJ, Gramegna M, Baldetti L, Beneduce A, Castelein T, Dauwe D, Frederiks P, Giustino G, Jacquemin M, Janssens SP, Panoulas VF, Poss J, Rosenberg A, Schaubroeck HAI, Schrage B, Tavazzi G, Vanassche T, Vercaemst L, Vlasselaers D, Vranckx P, Belohlavek J, Gorog DA, Huber K, Mebazaa A, Meyns B, Pappalardo F, Scandroglio AM, Stone GW, Westermann D, Chieffo A, Price S, Vandenbriele C. Management of Bleeding and Hemolysis During Percutaneous Microaxial Flow Pump Support: A Practical Approach. JACC Cardiovasc Interv. 2023 Jul 24;16(14):1707-1720. doi: 10.1016/j.jcin.2023.05.043.
PubMed 37495347Vandenbriele C, Arachchillage DJ, Frederiks P, Giustino G, Gorog DA, Gramegna M, Janssens S, Meyns B, Polzin A, Scandroglio M, Schrage B, Stone GW, Tavazzi G, Vanassche T, Vranckx P, Westermann D, Price S, Chieffo A. Anticoagulation for Percutaneous Ventricular Assist Device-Supported Cardiogenic Shock: JACC Review Topic of the Week. J Am Coll Cardiol. 2022 May 17;79(19):1949-1962. doi: 10.1016/j.jacc.2022.02.052.
PubMed 35550692Philipson DJ, Cohen DJ, Fonarow GC, Ziaeian B. Analysis of Adverse Events Related to Impella Usage (from the Manufacturer and User Facility Device Experience and National Inpatient Sample Databases). Am J Cardiol. 2021 Feb 1;140:91-94. doi: 10.1016/j.amjcard.2020.10.056. Epub 2020 Nov 2.
PubMed 33147430Amin AP, Spertus JA, Curtis JP, Desai N, Masoudi FA, Bach RG, McNeely C, Al-Badarin F, House JA, Kulkarni H, Rao SV. The Evolving Landscape of Impella Use in the United States Among Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support. Circulation. 2020 Jan 28;141(4):273-284. doi: 10.1161/CIRCULATIONAHA.119.044007. Epub 2019 Nov 17.
PubMed 31735078Dhruva SS, Ross JS, Mortazavi BJ, Hurley NC, Krumholz HM, Curtis JP, Berkowitz A, Masoudi FA, Messenger JC, Parzynski CS, Ngufor C, Girotra S, Amin AP, Shah ND, Desai NR. Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock. JAMA. 2020 Feb 25;323(8):734-745. doi: 10.1001/jama.2020.0254.
PubMed 32040163Moller JE, Engstrom T, Jensen LO, Eiskjaer H, Mangner N, Polzin A, Schulze PC, Skurk C, Nordbeck P, Clemmensen P, Panoulas V, Zimmer S, Schafer A, Werner N, Frydland M, Holmvang L, Kjaergaard J, Sorensen R, Lonborg J, Lindholm MG, Udesen NLJ, Junker A, Schmidt H, Terkelsen CJ, Christensen S, Christiansen EH, Linke A, Woitek FJ, Westenfeld R, Mobius-Winkler S, Wachtell K, Ravn HB, Lassen JF, Boesgaard S, Gerke O, Hassager C; DanGer Shock Investigators. Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock. N Engl J Med. 2024 Apr 18;390(15):1382-1393. doi: 10.1056/NEJMoa2312572. Epub 2024 Apr 7.
PubMed 38587239
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPELLA, Complications and Tolerance
- ClinicalTrials.gov ID
- NCT06644963
- Acronym / sponsor ID
- IMPACT / 2024-08-120
- Conditions
- Cardiogenic Shock
- Keywords
- Impella, pVAD, Bleeding, Thrombosis, hemocompatibily related adverse events
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 16 Oct 2024 (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.
Myocardial infarction complicated by cardiogenic shock (AMICS) is associated with high morbidity and mortality, and devices like Impella® CP and Impella 5.0-5.5 are often used for hemodynamic support, either alone or combined with veno-arterial ECMO (ECMELLA). While recent studies suggest improved survival with Impella® in cardiogenic shock, complications remain common, particularly due to deep arterial access and the need for anticoagulation. Hemocompatibility-related adverse events (HRAEs) such as ischemia, bleeding (44%), hemolysis (32%), and stroke (13%) frequently occur. Achieving hemocompatibility between the patient's blood and the device is challenging, as pump flow, anticoagulation, and patient factors contribute to both thrombotic and hemorrhagic complications. Despite advances, further research is required to better understand and reduce these risks in clinical practice.
Detailed description
Myocardial infarction complicated by cardiogenic shock (AMICS) is associated with high rates of morbidity and mortality. To provide hemodynamic support in these cases, intravascular microaxial left ventricular assist devices, such as Impella® CP and Impella 5.0-5.5, are frequently used, either alone in cardiogenic shock (CS) or in combination with veno-arterial ECMO (known as ECMELLA) for left ventricular unloading. Recent observational studies and randomized controlled trials have suggested improved survival rates with the use of Impella® in cardiogenic shock patients.
Despite the growing use of these devices, complications in clinical practice remain frequent. Due to the need for deep arterial access (14F for Impella CP and 21F for Impella 5.0) via femoral or axillary routes, as well as the necessity of anticoagulation, hemocompatibility-related adverse events (HRAEs) such as ischemic complications and bleeding are common, occurring in 18% and 44% of patients, respectively. Hemolysis has been reported in up to 32% of cases, while stroke affects up to 13%. Other less frequent complications include device deployment issues, pump thrombosis, implant site infections, and sepsis, all contributing to increased healthcare costs.
Achieving hemocompatibility between the patient's blood and the device remains a significant challenge despite advances in Impella technology. Balancing prothrombotic and prohemorrhagic forces at the blood/device interface is complex. This interface activates the coagulation cascade, generating a prothrombotic state, damaging von Willebrand multimers, and leading to hemolysis. The interplay of pump flow, pump speed, patient risk factors, and clinical management (anticoagulation) further complicates hemocompatibility, often resulting in thrombotic or bleeding events such as hemorrhagic stroke, circuit clots, or ischemic stroke.
Although the occurrence of HRAEs is well documented, particularly in the case of severe events like stroke, there is still an incomplete understanding of the factors driving these complications in modern clinical practice. Further research is needed to better delineate the risk factors and improve outcomes for patients receiving Impella support.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients admitted for cardiogenic shock supported by Impella (5, 5.5 or CP) between January 1, 2010, and December 31, 2022 (as an isolated circulatory support or combined with others Temporary Mechanical Circulatory Support)
Key inclusion criteria (1 listed)
- Adult patients admitted for cardiogenic shock supported by Impella (5, 5.5 or CP) between January 1, 2010, and December 31, 2022 (as an isolated circulatory support or combined with others Temporary Mechanical Circulatory Support)
Key exclusion criteria (3 listed)
- Absence of Impella
- Impella 2.5
- Impella RP (right)
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 |
|---|---|---|
| Impella (5, 5.5 or CP)Impella (5, 5.5 or CP) as an isolated circulatory support or combined with others Temporary Mechanical Circulatory Support | Device | – |
Primary outcome
Hemocompatibility related adverse events (HRAEs)
Time frame: From start of hospitalization until hospital discharge, assessed up to 3 month
Incidence of HRAEs with Impella (CP and/or 5 - 5.5) : Bleeding events (BARC >3b) and Thrombosis events ( ischemic stroke + pump thrombosis)
5 secondary outcomes
Early mortality
Time frame: From start of hospitalization until hospital discharge, assessed up to 3 month
Adverse events related to Impella devices
Time frame: From start of hospitalization until hospital discharge assessed up to 3 month
Duration of mechanical ventilation
Time frame: From start of hospitalization until hospital discharge, assessed up to 3 month
Lengh of stay
Time frame: From start of hospitalization until hospital discharge, assessed up to 3 month
Cardiac long-term project
Time frame: From start of hospitalization until hospital discharge assessed up to 3 month
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 16 Oct 2024.
- Results publication: PubMed 37495347Van Edom CJ, Gramegna M, Baldetti L, Beneduce A, Castelein T, Dauwe D, Frederiks P, Giustino G, Jacquemin M, Janssens SP, Panoulas VF, Poss J, Rosenberg A, Schaubroeck HAI, Schrage B, Tavazzi G, Vanassche T, Vercaemst L, Vlasselaers D, Vranckx P, Belohlavek J, Gorog DA, Huber K, Mebazaa A, Meyns B, Pappalardo F, Scandroglio AM, Stone GW, Westermann D, Chieffo A, Price S, Vandenbriele C. Management of Bleeding and Hemolysis During Percutaneous Microaxial Flow Pump Support: A Practical Approach. JACC Cardiovasc Interv. 2023 Jul 24;16(14):1707-1720. doi: 10.1016/j.jcin.2023.05.043.
- Results publication: PubMed 35550692Vandenbriele C, Arachchillage DJ, Frederiks P, Giustino G, Gorog DA, Gramegna M, Janssens S, Meyns B, Polzin A, Scandroglio M, Schrage B, Stone GW, Tavazzi G, Vanassche T, Vranckx P, Westermann D, Price S, Chieffo A. Anticoagulation for Percutaneous Ventricular Assist Device-Supported Cardiogenic Shock: JACC Review Topic of the Week. J Am Coll Cardiol. 2022 May 17;79(19):1949-1962. doi: 10.1016/j.jacc.2022.02.052.
- Results publication: PubMed 33147430Philipson DJ, Cohen DJ, Fonarow GC, Ziaeian B. Analysis of Adverse Events Related to Impella Usage (from the Manufacturer and User Facility Device Experience and National Inpatient Sample Databases). Am J Cardiol. 2021 Feb 1;140:91-94. doi: 10.1016/j.amjcard.2020.10.056. Epub 2020 Nov 2.
- Results publication: PubMed 31735078Amin AP, Spertus JA, Curtis JP, Desai N, Masoudi FA, Bach RG, McNeely C, Al-Badarin F, House JA, Kulkarni H, Rao SV. The Evolving Landscape of Impella Use in the United States Among Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support. Circulation. 2020 Jan 28;141(4):273-284. doi: 10.1161/CIRCULATIONAHA.119.044007. Epub 2019 Nov 17.
- Results publication: PubMed 32040163Dhruva SS, Ross JS, Mortazavi BJ, Hurley NC, Krumholz HM, Curtis JP, Berkowitz A, Masoudi FA, Messenger JC, Parzynski CS, Ngufor C, Girotra S, Amin AP, Shah ND, Desai NR. Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock. JAMA. 2020 Feb 25;323(8):734-745. doi: 10.1001/jama.2020.0254.
- Results publication: PubMed 38587239Moller JE, Engstrom T, Jensen LO, Eiskjaer H, Mangner N, Polzin A, Schulze PC, Skurk C, Nordbeck P, Clemmensen P, Panoulas V, Zimmer S, Schafer A, Werner N, Frydland M, Holmvang L, Kjaergaard J, Sorensen R, Lonborg J, Lindholm MG, Udesen NLJ, Junker A, Schmidt H, Terkelsen CJ, Christensen S, Christiansen EH, Linke A, Woitek FJ, Westenfeld R, Mobius-Winkler S, Wachtell K, Ravn HB, Lassen JF, Boesgaard S, Gerke O, Hassager C; DanGer Shock Investigators. Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock. N Engl J Med. 2024 Apr 18;390(15):1382-1393. doi: 10.1056/NEJMoa2312572. Epub 2024 Apr 7.
- 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.
Aurore UGHETTO, MD principal investigator
University Hospital, Montpellier
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 Cardiogenic Shock, run by University Hospital, Montpellier at 1 site in France.
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 3 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 16 Oct 2024. 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 France. 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 Aurore UGHETTO, MD (+33622054893, a-ughetto@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemocompatibility related adverse events (HRAEs) (time frame: From start of hospitalization until hospital discharge, assessed up to 3 month). 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 NCT06644963, which also lists 6 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 16 Oct 2024.