IMPACT EU Post-Market Clinical Follow-Up Study

September 29, 2025 updated by: Abiomed Inc.

IMpella®-Protected cArdiaC Surgery Trial in Europe: A European, Prospective, Multicenter, Post-Market Clinical Follow-Up Trial

The purpose of this trial is to collect further data on the safety and on the effectiveness of the use of Impella 5.5® in high-risk cardiac surgery patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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

A European, prospective, multicenter, post-market clinical single-arm follow-up trial.

Up to 123 patients will be enrolled in the study.

Patients will be followed for up to 1-year.

The objectives of the study are to collect data on the safety and on the effectiveness of the Impella 5.5 System in mitigating post-cardiotomy cardiac failure, as well as improving functional status and quality of life (QoL) in high-risk cardiac surgery patients with severe LV dysfunction in a post-market setting.

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.
Interventional

Enrollment (Actual)

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.
123

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Czechia
      • Prague, Czechia, 14021
        • IKEM Prague
  • Germany
      • Berlin, Germany, 13353
        • Deutsches Herzzentrum der Charité
      • Giessen, Germany, 35392
        • Universitätsklinikum Gießen
      • Hamburg, Germany, 20246
        • Universitäres Herz- und Gefäßzentrum Hamburg - Klinik und Poliklinik für Herz- und Gefäßchirurgie
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Trier, Germany, 54292
        • Krankenhaus der Barmherzigen Bruder Trier
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Universitätsklinikum Heidelberg - Klinik für Herzchirurgie
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Germany, 52074
        • RWTH Uniklinik Aachen - Klinik für Herzchirurgie
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Universitätsklinikum Düsseldorf, Klinik für Herzchirurgie
      • Essen, North Rhine-Westphalia, Germany, 45147
        • Universitätsmedizin Essen, Westdeutsches Herzzentrum, Klinik für Thorax- und Kardiovaskuläre Medizin
    • RLP
      • Mainz, RLP, Germany, 55131
        • Universitätsmedizin Mainz, Klinik und Poliklinik für Herz- und Gefäßchirurgie
    • SA
      • Halle, SA, Germany, 06120
        • Universitätsmedizin Halle/Saale - Klinik für Herzchirurgie
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • UKSH Campus Kiel - Klinik für Herz- und Gefäßchirurgie

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Hemodynamically stable patients undergoing one (1) of the following cardiac surgery procedures on CPB including aortic cross-clamping and cardioplegic arrest

    • Isolated CABG
    • Isolated mitral valve repair or replacement (MVR)
    • Isolated aortic valve repair or replacement (AVR)
    • At lest two of the following: CABG, MVR, AVR, or tricuspid valve repair or replacement (TVR)

  2. LVEF within 30 days before surgery of either:

    • ≤25% measured by echocardiogram or
    • LVEF ≤35% as above for patients with significant mitral regurgitation (MR 3+ or 4+; see definition) and planned corrective mitral valve surgery (including MV replacement or repair)
  3. Age 18 years or older
  4. Subject has signed informed consent form and is willing and able to attend all follow-up visits and to perform all tests.
  5. Patient is eligible to receive the Impella 5.5 as per the current IFU.

Exclusion Criteria:

  1. Salvage operation (cardiac arrest within 24 hours prior to index surgery)
  2. Unresponsive state within 24 hours of the time of surgery
  3. Any inotrope within 72 hours of surgery
  4. Any mechanical MCS device (such as IABP, ECMO, Impella®, CentriMag™ or TandemHeart®) in place prior to informed consent
  5. RV dysfunction requiring mechanical or inotropic support preoperatively and/or likely to be needed postoperatively
  6. Index procedures requiring total circulatory arrest (TCA), such as aortic arch replacement, planned durable LVAD, durable RVAD, planned right-sided temporary mechanical support of any kind, total artificial heart (TAH), cardiac transplantation, pericardiectomy, pulmonary thromboendarterectomy and septal myectomy
  7. Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade or other conditions in which cardiac output is dependent on venous return
  8. Ventricular septal defect (VSD)
  9. Stroke within 30 days of the index cardiac surgical procedure
  10. Prior mantle field chest irradiation
  11. Prior solid organ or hematologic transplantation (heart, kidney, liver, lung, pancreas, bone marrow) or durable LVAD
  12. History of chronic dialysis
  13. Pre-existing liver dysfunction defined as Child-Pugh Class B or C
  14. Pre-existing pulmonary disease requiring home oxygen, or "severe pulmonary disease" determined by enrolling investigator
  15. Systemic active infection or evidence of systemic bacterial, fungal or viral infection within 72 hours before surgery (blood culture positive with leukocytosis)
  16. Confirmed COVID-19 infection within two (2) weeks prior to operation
  17. Pregnant or planning pregnancy within next 12 months. NOTE: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention.
  18. Participation in the active treatment or follow-up phase of another interventional clinical trial of an investigational drug or device which has not reached its primary endpoint
  19. Known contraindication to heparin; History of bleeding diathesis or known coagulopathy or will refuse blood transfusions
  20. Inability to perform aortic cross-clamp, such as due to porcelain aorta
  21. Any contraindication or condition that would prevent the ability to place Impella 5.5® (per current IFU), including LV thrombus and/or presence of a mechanical aortic valve
  22. Any organ condition, concomitant disease (e.g., psychiatric illness, current severe alcoholism or current drug abuse, cancer, hepatic or kidney disease), with life expectancy of ≤2 years or other abnormality that itself or the treatment of which, could interfere with the conduct of the trial or that, in the opinion of the investigator would pose an unacceptable risk to the subject in the trial.
  23. Subject has other medical, social or psychological problems that, in the opinion of the investigator, compromises the subject's ability to give written informed consent and/or to comply with trial procedures, including patients under guardianship
  24. Any subject considered to be part of a vulnerable population (as per ISO 14155)

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Other: Treatment with Impella 5.5 System
Device: Device: Impella 5.5 with SmartAssist
Patients who are deemed high-risk due to low preoperative ejection fraction undergoing cardiac surgery with cardiopulmonary bypass (CPB) which will be supported by the Impella 5.5 System.

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
the rate of post-cardiotomy cardiac failure
Time Frame: Through Hospital Discharge, on average 1 week
Through Hospital Discharge, on average 1 week
Stroke (as defined by STS)
Time Frame: 90 Days after procedure
Postoperative stroke (cerebrovascular accident) consisting of any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain that did not resolve within 24 hours.
90 Days after procedure
All-cause mortality
Time Frame: 90 Days after procedure
90 Days after procedure

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
Number of attempts to wean from CPB
Time Frame: Until CPB was removed, on average 72 hours
Until CPB was removed, on average 72 hours
Acute Kidney Injury (a modified KDIGO stages 2-3)
Time Frame: Within 7 days or at ICU discharge whichever comes first
Within 7 days or at ICU discharge whichever comes first
Major Hemolysis (defined by MCS-ARC)
Time Frame: Through Hospital Discharge, on average 1 week
Through Hospital Discharge, on average 1 week
Major Vascular Complications (defined by MCS-ARC)
Time Frame: Through Hospital Discharge, on average 1 week
Through Hospital Discharge, on average 1 week
Major Bleeding defined by STS
Time Frame: Through Hospital Discharge, on average 1 week
Bleeding requiring surgical intervention or fatal bleeding
Through Hospital Discharge, on average 1 week
All-cause Mortality
Time Frame: Up to 1-year post-op
Up to 1-year post-op
New requirement for renal replacement therapy (RRT)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Duration of mechanical ventilation
Time Frame: Through ICU Discharge, on average 3 days
Through ICU Discharge, on average 3 days
Adequate hemodynamic support
Time Frame: Until Pulmonary Artery Catheter was removed, on average 3 days
Until Pulmonary Artery Catheter was removed, on average 3 days
Vasoactive-inotropic score (VIS)
Time Frame: Through ICU Discharge, on average 3 days
Through ICU Discharge, on average 3 days
Cardiovascular mortality
Time Frame: Through Hospital Discharge, on average 1 week
Through Hospital Discharge, on average 1 week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical Success
Time Frame: Time of CPB removed, on average at 72 hours
The successful use of the Impella 5.5 device will be assessed by the proportion of patients who undergo successful Impella insertion, as well as the proportion of patients demonstrating successful wean off CPB
Time of CPB removed, on average at 72 hours
Length of ICU stay in days
Time Frame: Through ICU discharge, on average 3 days
Through ICU discharge, on average 3 days
Length of hospital stay in days
Time Frame: Through Hospital Discharge, on average 1 week
Through Hospital Discharge, on average 1 week
Quality of Life Assessment by Kansas City Cardiomyopathy Questionnaire KCCQ)
Time Frame: 90 days and 1-year post-op
KCCQ scores are scaled from 0 to 100. Lower scores representing the worse symptoms
90 days and 1-year post-op
Quality of Life by Assessment of physical activity
Time Frame: 90 days and 1-year post-op
(Katz Activities of Daily Living (ADL). A The summary score ranges from 0 (low function, dependent) to 8 (high function, independent).
90 days and 1-year post-op
Quality of Life (QoL) by assessing the ability to perform tasks necessary to live independently
Time Frame: 90 days and 1-year post-op
Assessed by LAWTON - BRODY instrumental activities of daily living scale (I.A.D.L.). A summary score ranges from 0 (Low, patient very dependent ) to 6 (high, patient independent)
90 days and 1-year post-op

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.
Abiomed Inc.

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: Hermann Reichenspurner, Prof. Dr. Dr., UKE Hamburg
  • Principal Investigator: Payam Akhyari, Prof. Dr., Westdeutsches Herz- und Gefäßzentrum Essen

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.
April 27, 2023

Primary Completion (Estimated)

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.
August 8, 2026

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.
August 8, 2026

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).
January 20, 2023

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.
March 3, 2023

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.
March 6, 2023

Study Record Updates

Last Update Posted (Estimated)

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.
September 30, 2025

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.
September 29, 2025

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.
September 1, 2025

More Information

Terms related to this study

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.
  • ABMD-CIP-22-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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