IMPELLA, Complications and Tolerance (IMPACT)

October 15, 2024 updated by: University Hospital, Montpellier
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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)

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Absence of Impella
  • Impella 2.5
  • Impella RP (right)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
From start of hospitalization until hospital discharge, assessed up to 3 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Early mortality
Time Frame: From start of hospitalization until hospital discharge, assessed up to 3 month
In-hospital all-cause mortality
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
Hemolysis; Bacteremia; Infection of the device insertion site or the device itself
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
Total duration of invasive mechanical ventilation
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
Total and in intensive care unit lenght of stay
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
Rate and % of patients with myocardial recovery, ventricular assist device or/and heart transplantation
From start of hospitalization until hospital discharge assessed up to 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aurore Ughetto, MD, Montpellier University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-08-120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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