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Left Ventricular DysfunctionNCT05756751

IMPACT EU Post-Market Clinical Follow-Up Study

A study testing Device: Impella 5.5 with SmartAssist in people with Left Ventricular Dysfunction, run by Abiomed Inc. at 13 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Left Ventricular Dysfunction
What is being tested?
Device: Impella 5.5 with SmartAssist
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
13 sitesin 2 countries
Study dates
27 Apr 2023to 8 Aug 2026
Phase
Interventional
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

Who may be able to join

  • 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)
  • LVEF within 30 days before surgery of either:
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  • ≤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)
  • Age 18 years or older
  • Subject has signed informed consent form and is willing and able to attend all follow-up visits and to perform all tests.
  • Patient is eligible to receive the Impella 5.5 as per the current IFU.

Who cannot join

  • Salvage operation (cardiac arrest within 24 hours prior to index surgery)
  • Unresponsive state within 24 hours of the time of surgery
  • Any inotrope within 72 hours of surgery
  • Any mechanical MCS device (such as IABP, ECMO, Impella®, CentriMag™ or TandemHeart®) in place prior to informed consent
  • RV dysfunction requiring mechanical or inotropic support preoperatively and/or likely to be needed postoperatively
  • 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
Show all 24Show fewer
  • Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade or other conditions in which cardiac output is dependent on venous return
  • Ventricular septal defect (VSD)
  • Stroke within 30 days of the index cardiac surgical procedure
  • Prior mantle field chest irradiation
  • Prior solid organ or hematologic transplantation (heart, kidney, liver, lung, pancreas, bone marrow) or durable LVAD
  • History of chronic dialysis
  • Pre-existing liver dysfunction defined as Child-Pugh Class B or C
  • Pre-existing pulmonary disease requiring home oxygen, or "severe pulmonary disease" determined by enrolling investigator
  • Systemic active infection or evidence of systemic bacterial, fungal or viral infection within 72 hours before surgery (blood culture positive with leukocytosis)
  • Confirmed COVID-19 infection within two (2) weeks prior to operation
  • 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.
  • 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
  • Known contraindication to heparin; History of bleeding diathesis or known coagulopathy or will refuse blood transfusions
  • Inability to perform aortic cross-clamp, such as due to porcelain aorta
  • 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
  • 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.
  • 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
  • Any subject considered to be part of a vulnerable population (as per ISO 14155)

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

Germany12 sites

  • RWTH Uniklinik Aachen - Klinik für Herzchirurgie

    Aachen, North Rhine-Westphalia, 52074

  • Deutsches Herzzentrum der Charité

    Berlin, 13353

  • Universitätsklinikum Düsseldorf, Klinik für Herzchirurgie

    Düsseldorf, North Rhine-Westphalia, 40225

  • Universitätsmedizin Essen, Westdeutsches Herzzentrum, Klinik für Thorax- und Kardiovaskuläre Medizin

    Essen, North Rhine-Westphalia, 45147

  • Universitätsklinikum Giessen

    Giessen, 35392

  • Universitätsmedizin Halle/Saale - Klinik für Herzchirurgie

    Halle, SA, 06120

  • Universitäres Herz- und Gefäßzentrum Hamburg - Klinik und Poliklinik für Herz- und Gefäßchirurgie

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Heidelberg - Klinik für Herzchirurgie

    Heidelberg, Baden-Wurttemberg, 69120

  • UKSH Campus Kiel - Klinik für Herz- und Gefäßchirurgie

    Kiel, Schleswig-Holstein, 24105

  • Universitätsmedizin Mainz, Klinik und Poliklinik für Herz- und Gefäßchirurgie

    Mainz, RLP, 55131

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, 54292

Other trials in Germany

Czechia1 site

  • IKEM Prague

    Prague, 14021

Other trials in Czechia

About this study

Official title: 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.

Read the 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.

Being tested
Device: Impella 5.5 with SmartAssist
Medical subject headings
Ventricular Dysfunction, Left

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Device: Impella 5.5 with SmartAssistDevice

    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.

Study groups in NCT05756751
Study groupRoleWhat they receive
Treatment with Impella 5.5 SystemOtherNot described
Receives: Device: Device: Impella 5.5 with SmartAssist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the rate of post-cardiotomy cardiac failure

    Measured: Through Hospital Discharge, on average 1 week

  2. All-cause mortality

    Measured: 90 Days after procedure

  3. Stroke (as defined by STS)

    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.

    Measured: 90 Days after procedure

Secondary outcomes (11)

  1. New requirement for renal replacement therapy (RRT)

    Measured: through study completion, an average of 1 year

  2. Number of attempts to wean from CPB

    Measured: Until CPB was removed, on average 72 hours

  3. Duration of mechanical ventilation

    Measured: Through ICU Discharge, on average 3 days

  4. Acute Kidney Injury (a modified KDIGO stages 2-3)

    Measured: Within 7 days or at ICU discharge whichever comes first

  5. Adequate hemodynamic support

    Measured: Until Pulmonary Artery Catheter was removed, on average 3 days

  6. Vasoactive-inotropic score (VIS)

    Measured: Through ICU Discharge, on average 3 days

  7. Cardiovascular mortality

    Measured: Through Hospital Discharge, on average 1 week

  8. Major Hemolysis (defined by MCS-ARC)

    Measured: Through Hospital Discharge, on average 1 week

  9. Major Vascular Complications (defined by MCS-ARC)

    Measured: Through Hospital Discharge, on average 1 week

  10. Major Bleeding defined by STS

    Bleeding requiring surgical intervention or fatal bleeding

    Measured: Through Hospital Discharge, on average 1 week

  11. All-cause Mortality

    Measured: Up to 1-year post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2023
  2. Study start27 Apr 2023
  3. Primary completion8 Aug 2026 (estimated)
  4. Study completion8 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Impella 5.5® with SmartAssist® (Impella 5.5®)
Masking
None (open label)
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05756751
Sponsor's protocol ID
ABMD-CIP-22-03
Status last verified
Sep 2025
First submitted
20 Jan 2023
Last updated
30 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Device: Impella 5.5 with SmartAssist in people with Left Ventricular Dysfunction, run by Abiomed Inc. at 13 sites in 2 countries.

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 11 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany, Czechia. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the rate of post-cardiotomy cardiac failure (time frame: Through Hospital Discharge, on average 1 week). The study lists 3 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 NCT05756751.

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 30 Sep 2025.

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